Insulin ResistanceAgingNCT04372849
Effects of Age and Obesity on Brain Insulin Sensitivity
A study testing Human nasal insulin in people with Insulin Resistance and Obesity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. Recent evidence from clinical studies have shown that T2D almost doubles the risk for dementia. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Obesity
- What is being tested?
- Human nasal insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 28 Apr 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body-Mass Index (BMI) between 19-35 kg/m2
- HbA1c ≤6.0%
- normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
Who cannot join
- Not removable metal parts in or on the body
- manifest cardiovascular disease
- claustrophobia
- recent surgery (less than 3 months)
- Simultaneous participation in other studies
- Acute disease or infection within the last 4 weeks
Show all 10Show fewer
- neurological and psychiatric disorders
- treatment with centrally acting drugs
- hemoglobin Hb <13g / dl
- Hypersensitivity to any of the substances used
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
Official title: Insulinsensitivität Des Menschlichen Zentralnervensystems Mit Fortschreitendem Alter: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin
Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. Recent evidence from clinical studies have shown that T2D almost doubles the risk for dementia. As the population gets older, age-related chronic diseases, as T2D, become more prevalent. Scientific evidence is emerging that there are several links between metabolic and neurocognitive functions. Impaired insulin action (i.e. insulin resistance), the main hallmark of T2D, has been suggested as a likely shared common pathophysiological mechanism. However, the neural processes that determine how insulin resistance is are connected to the onset and progression of T2D and dementia remain unclear. In this context, the overall aim is to study brain insulin resistance to disentangle age-related and obesity related brain insulin resistance in healthy normal and overweight/obese persons at the age of 20 to 70 years . To this end, the investigators will assess brain insulin action using intranasal insulin/placebo during functional Magnetic Resonance Imaging (fMRI). Additionally, structural changes and cognitive processes will be assessed as secondary variables.
- Conditions
- Insulin Resistance, Obesity
- Being tested
- Human nasal insulin, Placebo
- Medical subject headings
- Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human nasal insulinOther
single dose of 160 U of human insulin as nasal spray
PlaceboOther
Single dose of placebo solution as nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Nasal insulin spray | Active comparator | Not described Receives: Other: Human nasal insulin |
| Placebo spray | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain insulin sensitivity in different age,weight and sex groups
fMRI measurement will be performed before and after administration of 160 U of human insulin or placebo as nasal spray. Changes in regional brain activity will be quantified by cerebral blood flow and blood oxygenation dependent (BOLD) signal to assess regional brain insulin sensitivity. Brain insulin sensitivity will be compared between eight groups (young normal weight men and women, young overweight/obese men and women, old normal weight men and women, old overweight/obese men and women). Persons are categorized into normal weight and overweight/obese based on the Body Mass Index (BMI). Age groups are build based on a median split.
Measured: 30 minutes after administration of nasal insulin
Secondary outcomes (4)
Whole-body insulin sensitivity
Insulin sensitivity will be estimated from a frequent-sampling 75 g oral glucose tolerance test (oGTT) using the Matsuda formula. Correlation of regional brain insulin sensitivity by intranasal insulin will be performed with whole-body insulin sensitivity based on oGTT. Changes in regional cerebral blood flow from before to after intranasal insulin administration will be assessed by functional magnetic resonance imaging (fMRI).
Measured: 2 hours
Correlation with autonomous nervous system activity
Correlation of the change in regional brain insulin sensitivity by intranasal insulin with the simultaneous change of the autonomous nervous system (measured by heart rate variability).
Measured: 10 - 150 minutes post nasal spray
Correlation with cognitive function
Correlation of the change in regional brain insulin sensitivity by intranasal insulin with cognitive measures addressed by neuropsychological testing.
Measured: 1 hours
Response to food cues
Brain response to food cues assessed by functional magnetic resonance imaging. Food cues will be rated for palatability on a visual analogue scale.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start28 Apr 2017
- Primary completion1 Dec 2019
- Study completion1 Mar 2020
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.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372849
- Sponsor's protocol ID
- 837/2016BO2
- Acronym
- Aging
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 Nov 2020
- 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulinsensitivität Des Menschlichen Zentralnervensystems Mit Fortschreitendem Alter: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin
- ClinicalTrials.gov ID
- NCT04372849
- Acronym / sponsor ID
- Aging / 837/2016BO2
- Conditions
- Insulin Resistance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 4 May 2020 (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.
Obesity and especially type 2 diabetes (T2D) increases the risk of neurocognitive dysfunctions including adverse effects on brain structure and function. Recent evidence from clinical studies have shown that T2D almost doubles the risk for dementia. As the population gets older, age-related chronic diseases, as T2D, become more prevalent. Scientific evidence is emerging that there are several links between metabolic and neurocognitive functions. Impaired insulin action (i.e. insulin resistance), the main hallmark of T2D, has been suggested as a likely shared common pathophysiological mechanism. However, the neural processes that determine how insulin resistance is are connected to the onset and progression of T2D and dementia remain unclear. In this context, the overall aim is to study brain insulin resistance to disentangle age-related and obesity related brain insulin resistance in healthy normal and overweight/obese persons at the age of 20 to 70 years . To this end, the investigators will assess brain insulin action using intranasal insulin/placebo during functional Magnetic Resonance Imaging (fMRI). Additionally, structural changes and cognitive processes will be assessed as secondary variables.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal insulin spray | Active comparator | Other: Human nasal insulin |
| Placebo spray | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body-Mass Index (BMI) between 19-35 kg/m2
- HbA1c ≤6.0%
- normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
Key exclusion criteria (10 listed)
- Not removable metal parts in or on the body
- manifest cardiovascular disease
- claustrophobia
- recent surgery (less than 3 months)
- Simultaneous participation in other studies
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 |
|---|---|---|
| Human nasal insulinsingle dose of 160 U of human insulin as nasal spray | Other | Nasal insulin spray |
| PlaceboSingle dose of placebo solution as nasal spray | Other | Placebo spray |
Primary outcome
Brain insulin sensitivity in different age,weight and sex groups
Time frame: 30 minutes after administration of nasal insulin
fMRI measurement will be performed before and after administration of 160 U of human insulin or placebo as nasal spray. Changes in regional brain activity will be quantified by cerebral blood flow and blood oxygenation dependent (BOLD) signal to assess regional brain insulin sensitivity. Brain insulin sensitivity will be compared between eight groups (young normal weight men and women, young overweight/obese men and women, old normal weight men and women, old overweight/obese men and women). Persons are categorized into normal weight and overweight/obese based on the Body Mass Index (BMI). Age groups are build based on a median split.
4 secondary outcomes
Whole-body insulin sensitivity
Time frame: 2 hours
Correlation with autonomous nervous system activity
Time frame: 10 - 150 minutes post nasal spray
Correlation with cognitive function
Time frame: 1 hours
Response to food cues
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human nasal insulin 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 3 inclusion and 10 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 5 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brain insulin sensitivity in different age,weight and sex groups (time frame: 30 minutes after administration of nasal insulin). 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 5 Nov 2020.