- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04372849
Effects of Age and Obesity on Brain Insulin Sensitivity (Aging)
November 4, 2020 updated by: University Hospital Tuebingen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tübingen, Germany, 72076
- University of Tuebingen, Department of Internal Medicine IV
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body-Mass Index (BMI) between 19-35 kg/m2
- HbA1c ≤6.0%
- normal glucose tolerance during 75g oral glucose tolerance test (OGTT)
Exclusion Criteria:
- 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
- neurological and psychiatric disorders
- treatment with centrally acting drugs
- hemoglobin Hb <13g / dl
- Hypersensitivity to any of the substances used
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nasal insulin spray
|
single dose of 160 U of human insulin as nasal spray
|
Placebo Comparator: Placebo spray
|
Single dose of placebo solution as nasal spray
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 minutes after administration of nasal insulin
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole-body insulin sensitivity
Time Frame: 2 hours
|
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).
|
2 hours
|
Correlation with autonomous nervous system activity
Time Frame: 10 - 150 minutes post nasal spray
|
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).
|
10 - 150 minutes post nasal spray
|
Correlation with cognitive function
Time Frame: 1 hours
|
Correlation of the change in regional brain insulin sensitivity by intranasal insulin with cognitive measures addressed by neuropsychological testing.
|
1 hours
|
Response to food cues
Time Frame: 20 minutes
|
Brain response to food cues assessed by functional magnetic resonance imaging.
Food cues will be rated for palatability on a visual analogue scale.
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2017
Primary Completion (Actual)
December 1, 2019
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
April 29, 2020
First Submitted That Met QC Criteria
April 29, 2020
First Posted (Actual)
May 4, 2020
Study Record Updates
Last Update Posted (Actual)
November 5, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 837/2016BO2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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