InsulinPhase 2NCT04292535

Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

A Phase 2 study testing 20 IU NovoLog Insulin aspart into the intranasal mucosa, 40 IU NovoLog Insulin aspart into the intranasal mucosa and 60 IU NovoLog Insulin aspart into the intranasal mucosa in people with Insulin and Exercise, run by Michigan State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Insulin, Exercise
What is being tested?: 20 IU NovoLog Insulin aspart into the intranasal mucosa, 40 IU NovoLog Insulin aspart into the intranasal mucosa and 60 IU NovoLog Insulin aspart into the intranasal mucosa
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 116 participants
Where: 1 siteUnited States
Study dates: 15 Jun 2018to 20 Feb 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants must be over the age of 18..
Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Who cannot join

Lack of consent.
Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.
Type I or Type II Diabetes
Self-reported pregnancy
Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Kinesiology
East Lansing, Michigan, 48824

Other trials in United States

About this study

Official title: Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise

To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

Read the detailed description

Using a randomized placebo controlled double-blind pre-posttest design, participants will be randomly assigned to receive a dose of either 0, 20, 40, 60, 80, 100, or 120 IU of NovoLog insulin aspart prior to being randomized into participating in a 20 minute session of either moderate-intensity aerobic exercise or a passive control condition. The efficacy of the intranasal insulin for inducing alterations in cognition will be assessed using both behavioral and neuroelectric measures. The safety of the protocol will be assessed using a symptom questionnaire assessing common symptoms of altered blood glucose and common side effects of intranasal insulin.

Conditions: Insulin, Exercise
Being tested: Placebo into the intranasal mucosa, 20 IU NovoLog Insulin aspart into the intranasal mucosa, 40 IU NovoLog Insulin aspart into the intranasal mucosa, 60 IU NovoLog Insulin aspart into the intranasal mucosa, 80 IU NovoLog Insulin aspart into the intranasal mucosa
Keywords: Intranasal Insulin, Cognition, Exercise, Physical Activity
Medical subject headings: Insulin Resistance, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo into the intranasal mucosaDrug
Also called Saline
6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
20 IU NovoLog Insulin aspart into the intranasal mucosaDrug
Also called NovoLog Insulin aspart
5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
40 IU NovoLog Insulin aspart into the intranasal mucosaDrug
Also called NovoLog Insulin aspart
4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
60 IU NovoLog Insulin aspart into the intranasal mucosaDrug
Also called NovoLog Insulin aspart
3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
80 IU NovoLog Insulin aspart into the intranasal mucosaDrug
Also called NovoLog Insulin aspart
2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
100 IU NovoLog Insulin aspart into the intranasal mucosaDrug
Also called NovoLog Insulin aspart
1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
120 IU NovoLog Insulin aspart into the intranasal mucosaDrug
Also called NovoLog Insulin aspart
6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer

Study groups in NCT04292535
Study group	Role	What they receive
Passive Control	Active comparator	20 minute sedentary control period during which participants watched an emotionally neutral video. Receives: Drug: Placebo into the intranasal mucosa; Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa
Acute Exercise	Experimental	20 minute physical activity period during which participants exercised on a treadmill at an intensity corresponding to 60-65% of maximum heart rate while watching an emotionally neutral video. Receives: Drug: Placebo into the intranasal mucosa; Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa; Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.
Measured: During the 20 minute exercise/control period and the cognitive assessments.
Number of Participants With Manifestation of Any Symptom Following the Protocol
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.
Measured: Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)
Effect Size for Change in Behavioral Index of Inhibitory Control - RT
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.
Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following
Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.
Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.
Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.
Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Behavioral Index of Sustained Attention - RT
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.
Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.
Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis.
Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Measured: Prior to intranasal insulin administration relative to 30 minutes following

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 201820 Feb 2020

First posted3 Mar 2020
Study start15 Jun 2018
Primary completion20 Feb 2020
Study completion20 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InsulinStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04292535
Sponsor's protocol ID: STUDY00000804
Status last verified: May 2021
First submitted: 28 Feb 2020
Last updated: 21 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.

Publications

Gwizdala KL, Ferguson DP, Kovan J, Novak V, Pontifex MB. Placebo controlled phase II clinical trial: Safety and efficacy of combining intranasal insulin & acute exercise. Metab Brain Dis. 2021 Aug;36(6):1289-1303. doi: 10.1007/s11011-021-00727-2. Epub 2021 Apr 15.
PubMed 33856613

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

All Insulin trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo Controlled Phase II Clinical Trial: Safety and Efficacy of Combining Intranasal Insulin & Acute Exercise
ClinicalTrials.gov ID: NCT04292535
Acronym / sponsor ID: STUDY00000804
Conditions: Insulin, Exercise
Keywords: Intranasal Insulin, Cognition, Exercise, Physical Activity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Study start: 15 Jun 2018 (actual)
Primary completion: 20 Feb 2020 (actual)
Study completion: 20 Feb 2020 (actual)
First posted: 3 Mar 2020 (actual)
Results: Posted 21 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if physical activity engagement alters the dose-response profile and safety of administration of insulin into the intranasal mucosa.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Random allocation to a dose of intranasal insulin (0, 20, 40, 60, 80, 100, 120) Within each dose, random allocation to exercise or control activity.

Arm	Type	Receives
Passive Control	Active comparator	Drug: Placebo into the intranasal mucosa, Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa20 minute sedentary control period during which participants watched an emotionally neutral video.
Acute Exercise	Experimental	Drug: Placebo into the intranasal mucosa, Drug: 20 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 40 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 60 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 80 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 100 IU NovoLog Insulin aspart into the intranasal mucosa, Drug: 120 IU NovoLog Insulin aspart into the intranasal mucosa20 minute physical activity period during which participants exercised on a treadmill at an intensity corresponding to 60-65% of maximum heart rate while watching an emotionally neutral video.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants must be over the age of 18..
Participants must have normal or corrected-to-normal vision in order to complete the cognitive task.

Key exclusion criteria (5 listed)

Lack of consent.
Presence of any major neurological health issues, brain trauma, or concussion with loss of consciousness assessed through a health history and demographics questionnaire.
Type I or Type II Diabetes
Self-reported pregnancy
Currently has any type of inflammation or blockage of the nasal passageways (i.e. allergies or a cold affecting the sinuses).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placebo into the intranasal mucosaAlso: Saline6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer	Drug	Acute Exercise, Passive Control
20 IU NovoLog Insulin aspart into the intranasal mucosaAlso: NovoLog Insulin aspart5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer	Drug	Acute Exercise, Passive Control
40 IU NovoLog Insulin aspart into the intranasal mucosaAlso: NovoLog Insulin aspart4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer	Drug	Acute Exercise, Passive Control
60 IU NovoLog Insulin aspart into the intranasal mucosaAlso: NovoLog Insulin aspart3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer	Drug	Acute Exercise, Passive Control
80 IU NovoLog Insulin aspart into the intranasal mucosaAlso: NovoLog Insulin aspart2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer	Drug	Acute Exercise, Passive Control
100 IU NovoLog Insulin aspart into the intranasal mucosaAlso: NovoLog Insulin aspart1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer	Drug	Acute Exercise, Passive Control
120 IU NovoLog Insulin aspart into the intranasal mucosaAlso: NovoLog Insulin aspart6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer	Drug	Acute Exercise, Passive Control

Primary outcome

Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol
Time frame: During the 20 minute exercise/control period and the cognitive assessments.
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. Burning/tingling of the nose and watering/tearing of the eyes during the nasal spray were the most cited symptoms.
Number of Participants With Manifestation of Any Symptom Following the Protocol
Time frame: Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments)
The manifestation of any symptom that could be associated with alterations in blood glucose and side effects of intranasal insulin. Fewer symptoms would indicate a better outcome. The most cited symptom was having a runny nose.
Effect Size for Change in Behavioral Index of Inhibitory Control - RT
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a flanker test of inhibitory control. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a flanker test of inhibitory control. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Effect Size of Change in Neuroelectric Index of Attentional Engagement - Inhibition Task
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - Inhibition Task
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the flanker test of inhibitory control. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Effect Size of Change in Behavioral Index of Sustained Attention - RT
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in behavioral metrics of performance (RT) on a Rapid Visual Information Processing test of sustained attention. A more negative effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Effect Size of Change in Behavioral Index of Sustained Attention - Accuracy
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in behavioral metrics of performance (response accuracy) on a Rapid Visual Information Processing test of sustained attention. A more positive effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Effect Size of Change in Neuroelectric Index of Attentional Engagement - RVIP Task
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b amplitude) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A larger effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.
Effect Size of Change in Neuroelectric Index of Attentional Processing Speed - RVIP Task
Time frame: Prior to intranasal insulin administration relative to 30 minutes following
The effect size of the change from pre-to-posttest in neuroelectric measures of attention (P3b latency) in response to the target trial of the Rapid Visual Information Processing test of sustained attention. The effect size was collapsed across a nine-channel region-of-interest centering around the topographic maxima of the P3 (i.e., the CP3/Z/4, P3/Z/4, PO5/Z/6 electrodes). A smaller effect size would indicate a better outcome. Effect sizes were computed for each participant as the standardized change relative to the pretest assessment using the within-subject (drm) variance correction for Cohen's d (Lakens, 2013). To ensure the integrity of the effect size estimates, within-subject effect sizes exceeding 3 times the interquartile range were identified as outliers and removed from analysis. Effect sizes are computed per Arm and do not reflect comparisons or combinations across Arms/Groups.

Results and safety

Results posted to the registry on 21 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Passive Control - Placebo	8	8
Passive Control - 20 IU	8	8
Passive Control - 40 IU	9	9
Passive Control - 60 IU	8	8
Passive Control - 80 IU	8	8
Passive Control - 100 IU	9	9
Passive Control - 120 IU	8	8
Acute Exercise - Placebo	10	8
Acute Exercise - 20 IU	8	8
Acute Exercise - 40 IU	8	8
Acute Exercise - 60 IU	7	7
Acute Exercise - 80 IU	7	6
Acute Exercise - 100 IU	9	8
Acute Exercise - 120 IU	9	7

Primary outcome: Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol

Time frame: During the 20 minute exercise/control period and the cognitive assessments.. Count of participants. Unit: Participants

Measure	Passive Control - Placebo n = 8	Passive Control - 20 IU n = 8	Passive Control - 40 IU n = 9	Passive Control - 60 IU n = 8	Passive Control - 80 IU n = 8	Passive Control - 100 IU n = 9	Passive Control - 120 IU n = 8	Acute Exercise - Placebo n = 10	Acute Exercise - 20 IU n = 8	Acute Exercise - 40 IU n = 8	Acute Exercise - 60 IU n = 7	Acute Exercise - 80 IU n = 7	Acute Exercise - 100 IU n = 9	Acute Exercise - 120 IU n = 9
Value	4	6	6	4	5	9	5	2	4	3	4	4	7	9

Primary outcome: Number of Participants With Manifestation of Any Symptom Following the Protocol

Time frame: Approximately 1 hour following the dose of intranasal insulin (~32 minutes following the end of the passive control/exercise condition; immediately following the completion of the post-test cognitive assessments). Count of participants. Unit: Participants

Measure	Passive Control - Placebo n = 8	Passive Control - 20 IU n = 8	Passive Control - 40 IU n = 9	Passive Control - 60 IU n = 8	Passive Control - 80 IU n = 8	Passive Control - 100 IU n = 9	Passive Control - 120 IU n = 8	Acute Exercise - Placebo n = 10	Acute Exercise - 20 IU n = 8	Acute Exercise - 40 IU n = 8	Acute Exercise - 60 IU n = 7	Acute Exercise - 80 IU n = 7	Acute Exercise - 100 IU n = 9	Acute Exercise - 120 IU n = 9
Value	1	2	0	2	1	4	3	0	1	2	1	0	3	2

Primary outcome: Effect Size for Change in Behavioral Index of Inhibitory Control - RT

Time frame: Prior to intranasal insulin administration relative to 30 minutes following. Mean (95% Confidence Interval). Unit: cohens d

Measure	Passive Control - Placebo n = 8	Passive Control - 20 IU n = 8	Passive Control - 40 IU n = 9	Passive Control - 60 IU n = 8	Passive Control - 80 IU n = 8	Passive Control - 100 IU n = 9	Passive Control - 120 IU n = 8	Acute Exercise - Placebo n = 8	Acute Exercise - 20 IU n = 8	Acute Exercise - 40 IU n = 8	Acute Exercise - 60 IU n = 7	Acute Exercise - 80 IU n = 7	Acute Exercise - 100 IU n = 8	Acute Exercise - 120 IU n = 7
Value	-0.04 (-0.17 to 0.09)	-0.29 (-0.45 to -0.13)	-0.54 (-0.81 to -0.27)	-0.10 (-0.38 to 0.18)	-0.42 (-0.61 to -0.23)	-0.25 (-0.54 to -0.03)	-0.10 (-0.29 to 0.09)	-0.08 (-0.26 to 0.10)	-0.20 (-0.40 to 0.01)	-0.25 (-0.42 to -0.08)	-0.33 (-0.63 to -0.04)	-0.19 (-0.42 to 0.04)	-0.27 (-0.57 to 0.03)	-0.36 (-0.55 to -0.16)

Primary outcome: Effect Size for Change in Behavioral Index of Inhibitory Control - Accuracy

Time frame: Prior to intranasal insulin administration relative to 30 minutes following. Mean (95% Confidence Interval). Unit: cohens d

Measure	Passive Control - Placebo n = 8	Passive Control - 20 IU n = 8	Passive Control - 40 IU n = 9	Passive Control - 60 IU n = 8	Passive Control - 80 IU n = 8	Passive Control - 100 IU n = 9	Passive Control - 120 IU n = 8	Acute Exercise - Placebo n = 8	Acute Exercise - 20 IU n = 8	Acute Exercise - 40 IU n = 8	Acute Exercise - 60 IU n = 7	Acute Exercise - 80 IU n = 7	Acute Exercise - 100 IU n = 8	Acute Exercise - 120 IU n = 7
Value	-0.03 (-0.28 to 0.22)	0.16 (-0.17 to 0.49)	-0.04 (-0.28 to 0.21)	-0.19 (-0.40 to 0.02)	-0.06 (-0.37 to 0.26)	-0.14 (-0.46 to 0.19)	-0.05 (-0.14 to 0.05)	0.05 (-0.23 to 0.33)	-0.26 (-0.74 to 0.23)	-0.12 (-0.51 to 0.28)	0.06 (-0.18 to 0.29)	-0.01 (-0.25 to 0.23)	0.01 (-0.26 to 0.27)	-0.13 (-0.46 to 0.20)

Adverse events

Time frame: Only during the two 90 minute sessions.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Passive Control - Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Passive Control - 20 IU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Passive Control - 40 IU	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Passive Control - 60 IU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Passive Control - 80 IU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Passive Control - 100 IU	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Passive Control - 120 IU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Acute Exercise - Placebo	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Acute Exercise - 20 IU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Acute Exercise - 40 IU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Acute Exercise - 60 IU	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Acute Exercise - 80 IU	0 of 7 (0%)	0 of 7 (0%)	0 of 7
Acute Exercise - 100 IU	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
Acute Exercise - 120 IU	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9

Limitations and caveats (from the sponsor): As the present investigation was a Phase II Clinical Trial, the research design was not sufficiently powered for hypothesis testing. Given the potential risk of combining exercise with intranasal insulin the present investigation utilized a sample of healthy, non-diabetic, fasted college-aged adults to limit the potential for a serious adverse event.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33856613Gwizdala KL, Ferguson DP, Kovan J, Novak V, Pontifex MB. Placebo controlled phase II clinical trial: Safety and efficacy of combining intranasal insulin & acute exercise. Metab Brain Dis. 2021 Aug;36(6):1289-1303. doi: 10.1007/s11011-021-00727-2. Epub 2021 Apr 15.
Individual participant dataSharing planned: Yes. Data sharing will be by request and approval of the Michigan State University Human Research Protections Program with the provision of a data-safety and sharing agreement. No individually identifiable information will be shared.

Related trials for Insulin

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew B Pontifex, Ph.D. principal investigator

Michigan State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Manifestation of Any Symptom at Any Point During the Protocol (time frame: During the 20 minute exercise/control period and the cognitive assessments.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292535, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.