Insulin ResistanceacExNCT06039787
Exercise Training on Brain Insulin Responsiveness
A study testing single bout of moderate intensity continuous training (MICT) and single bout of High Intensity Interval Training (HIIT) in people with Insulin Resistance and Obesity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The overarching goal of the current study is to investigate the effect of one acute bout of exercise on the brain insulin responsiveness in a cross-over study design. To this end, investigators will compare the effect of two single endurance exercise sessions with different intensities, namely moderate intensity… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- single bout of moderate intensity continuous training (MICT) and single bout of High Intensity Interval Training (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 20 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between ≥ 19.5 to 39 kg/m2-
- Less than 150 min/week for moderate-intensity physical activity
- Less than 75 min/week for Vigorous- intensity exercise (WHO recommendations for regular physical activity of adults)
- Written consent to participate in the study
- Written consent to be informed about incidental findings
Who cannot join
- Type 2 diabetes, cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
- Limitations to participate in ergometer-based exercise (balance and coordination disorders, orthopedic problems, …)
- Insufficient knowledge of the German language
- Persons who cannot legally give consent
- Pregnancy or lactation
- History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures and migraines)
Show all 19Show fewer
- Taking psychotropic drugs
- Taking medications that influence glucose metabolism
- Regular use of analgesic drugs
- Taking anticoagulant agents
- Previous bariatric surgery
- Acute infection within the last 4 weeks
- Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men
- Other diseases that in the opinion of the investigator may jeopardize the success of the study or indicate a risk to the volunteer
- Current participation in a lifestyle intervention study or a pharmaceutical study
- Metal implants which cannot be removed as pacemakers, artificial heart valve, electrical devices as insulin pumps, large tattoos, retainer over more than 4 teeth, contraceptive coil, implanted magnetic metal parts as screws or plates after a surgery
- Persons with claustrophobia
- Temperature-sensitive person
- Persons with tinnitus or increased sensitivity to loud sounds
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Tübingen, Department of Internal Medicine IV
Tübingen, 72076
Stephanie Kullmann, PhD, +49 7071 29 ext. 87703, stephanie.kullmann@med.uni-tuebingen.de
About this study
Official title: Effects of One Exercise Training Session on Brain Insulin Responsiveness
The overarching goal of the current study is to investigate the effect of one acute bout of exercise on the brain insulin responsiveness in a cross-over study design. To this end, investigators will compare the effect of two single endurance exercise sessions with different intensities, namely moderate intensity continuous training (MICT) and high-intensity-interval-training (HIIT), which will be performed in a randomized order. This will be compared to a waiting control condition.
Read the detailed description
Investigate one acute bout of exercise on the brain insulin responsiveness using functional magnetic resonance imaging in combination with intranasal insulin in healthy participants of normal-weight and overweight/obesity. Two single endurance exercise sessions with different intensities will be evaluated, namely moderate intensity continuous training (MICT) and high-intensity interval training (HIIT). This will be compared to a waiting control condition. In a cross-over design, investigators will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise. Cerebral response is defined as the cerebral blood flow and resting state functional connectivity in response to intranasal insulin. Secondary outcomes include changes in blood metabolites and proteins and changes in eating behavior.
- Conditions
- Insulin Resistance, Obesity
- Being tested
- single bout of moderate intensity continuous training (MICT), single bout of High Intensity Interval Training (HIIT), waiting control
- Keywords
- Exercise, functional magnetic resonance imaging, Intranasal insulin
- Medical subject headings
- Insulin Resistance, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single bout of moderate intensity continuous training (MICT)Behavioural
the MICT consists of 60 min continuous cycling
single bout of High Intensity Interval Training (HIIT)Behavioural
HIIT consists of 10-min warm-up at the power output corresponding to 50% peak power output (PPO), 4 x 4-min intervals at a power output corresponding to 75% PPO with a 4-min active resting period at 30% PPO to recover
waiting controlBehavioural
sitting in a waiting room for 60 min
| Study group | Role | What they receive |
|---|---|---|
| moderate intensity continuous training | Experimental | Not described Receives: Behavioral: single bout of moderate intensity continuous training (MICT) |
| High-intensity interval training | Experimental | Not described Receives: Behavioral: single bout of High Intensity Interval Training (HIIT) |
| Waiting condition | Placebo comparator | Not described Receives: Behavioral: waiting control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral response after intranasal insulin administration
The resting-state cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Measured: 1 hour after exercise or waiting control
Secondary outcomes (6)
Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition
Food cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Measured: 1 hour after exercise or waiting control
Subjective feeling of hunger and food craving
Questionnaire assessment before and after exercise or waiting control.
Measured: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Changes in Blood-brain barrier integrity
Robust multiple echo-time arterial spin labelling based Blood Brain Barrier integrity measurements from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Measured: 1 hour after exercise or waiting control
Performance during cognitive tasks
Cambridge Cognition Tests Battery to assess memory and inhibitory control using the paired associates learning task, the pattern recognition memory task and the stop-signal reaction task.
Measured: 1 hour after exercise or waiting control
Changes in exerkines from plasma samples
Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Measured: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Change in incretins from plasma samples
Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Measured: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start20 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In a cross-over design, we will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas L. Birkenfeld, MD, Study director, Institute for Diabetes research and Metabolic Diseases at the University of Tubingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039787
- Sponsor's protocol ID
- 226/2023BO2
- Acronym
- acEx
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of One Exercise Training Session on Brain Insulin Responsiveness
- ClinicalTrials.gov ID
- NCT06039787
- Acronym / sponsor ID
- acEx / 226/2023BO2
- Conditions
- Insulin Resistance, Obesity
- Keywords
- Exercise, functional magnetic resonance imaging, Intranasal insulin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overarching goal of the current study is to investigate the effect of one acute bout of exercise on the brain insulin responsiveness in a cross-over study design. To this end, investigators will compare the effect of two single endurance exercise sessions with different intensities, namely moderate intensity continuous training (MICT) and high-intensity-interval-training (HIIT), which will be performed in a randomized order. This will be compared to a waiting control condition.
Detailed description
Investigate one acute bout of exercise on the brain insulin responsiveness using functional magnetic resonance imaging in combination with intranasal insulin in healthy participants of normal-weight and overweight/obesity. Two single endurance exercise sessions with different intensities will be evaluated, namely moderate intensity continuous training (MICT) and high-intensity interval training (HIIT). This will be compared to a waiting control condition. In a cross-over design, investigators will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise. Cerebral response is defined as the cerebral blood flow and resting state functional connectivity in response to intranasal insulin. Secondary outcomes include changes in blood metabolites and proteins and changes in eating behavior.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- In a cross-over design, we will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise.
| Arm | Type | Receives |
|---|---|---|
| moderate intensity continuous training | Experimental | Behavioral: single bout of moderate intensity continuous training (MICT) |
| High-intensity interval training | Experimental | Behavioral: single bout of High Intensity Interval Training (HIIT) |
| Waiting condition | Placebo comparator | Behavioral: waiting control |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI between ≥ 19.5 to 39 kg/m2-
- Less than 150 min/week for moderate-intensity physical activity
- Less than 75 min/week for Vigorous- intensity exercise (WHO recommendations for regular physical activity of adults)
- Written consent to participate in the study
- Written consent to be informed about incidental findings
Key exclusion criteria (19 listed)
- Type 2 diabetes, cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
- Limitations to participate in ergometer-based exercise (balance and coordination disorders, orthopedic problems, …)
- Insufficient knowledge of the German language
- Persons who cannot legally give consent
- Pregnancy or lactation
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 |
|---|---|---|
| single bout of moderate intensity continuous training (MICT)the MICT consists of 60 min continuous cycling | Behavioural | moderate intensity continuous training |
| single bout of High Intensity Interval Training (HIIT)HIIT consists of 10-min warm-up at the power output corresponding to 50% peak power output (PPO), 4 x 4-min intervals at a power output corresponding to 75% PPO with a 4-min active resting period at 30% PPO to recover | Behavioural | High-intensity interval training |
| waiting controlsitting in a waiting room for 60 min | Behavioural | Waiting condition |
Primary outcome
Cerebral response after intranasal insulin administration
Time frame: 1 hour after exercise or waiting control
The resting-state cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
6 secondary outcomes
Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition
Time frame: 1 hour after exercise or waiting control
Subjective feeling of hunger and food craving
Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Changes in Blood-brain barrier integrity
Time frame: 1 hour after exercise or waiting control
Performance during cognitive tasks
Time frame: 1 hour after exercise or waiting control
Changes in exerkines from plasma samples
Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Change in incretins from plasma samples
Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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.
Andreas L. Birkenfeld, MD study director
Institute for Diabetes research and Metabolic Diseases at the University of Tubingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single bout of moderate intensity continuous training (MICT) and single bout of High Intensity Interval Training (HIIT) in people with Insulin Resistance and Obesity, run by University Hospital Tuebingen at 1 site in Germany.
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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 8 Nov 2023. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Kullmann, PhD (0049707129 ext. 87703, stephanie.kullmann@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral response after intranasal insulin administration (time frame: 1 hour after exercise or waiting control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2023.