Impact of weight loss on brain insulin sensitivity
Effekt Von Gewichtsabnahme Auf Die zentralnervöse Insulinresistenz Des Menschen
This study is testing whether losing weight can help improve how the brain responds to insulin in people who have insulin resistance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT02991365 on ClinicalTrials.gov |
What this trial studies
This study investigates how weight loss affects brain insulin sensitivity in humans, particularly focusing on individuals with insulin resistance. Participants will undergo brain imaging using fMRI while receiving intranasal insulin or a placebo over an 8-week period. The goal is to determine if weight loss can improve insulin sensitivity in the brain, which may have broader implications for energy regulation in the body.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 75 years with HbA1c levels below 6.5% who are not on antidiabetic or weight loss medications.
Not a fit: Patients with significant cardiovascular disease, neurological or psychiatric disorders, or those who are claustrophobic may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for treating insulin resistance and obesity-related conditions.
How similar studies have performed: Previous research in animal models has shown that weight loss can improve brain insulin sensitivity, but this approach is being tested in humans for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HbA1c \<6.5% * Age between 40 and 75 years * No intake of antidiabetic drugs or drugs for weight reduction * no steroid intake * Stable medication over 10 weeks before the start of the study Exclusion Criteria: * Persons who wear non-removable metal parts in or on the body. * Persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body * Cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition * Persons with hearing impairment or increased sensitivity to loud noises * People with claustrophobia * Minors or non-consenting subjects are also excluded * Subjects with an operation less than 3 months * Simultaneous participation in other studies * Neurological and psychiatric disorders * Subjects with hemoglobin Hb \<11 g / dl * Hypersensitivity to any of the substances used
Where this trial is running
Tübingen
- University of Tuebingen, Department of Internal Medicine IV — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Andreas Fritsche, MD — University of Tübingen Hospital
- Study coordinator: Andreas Fritsche, MD
- Email: andreas.fritsche@med.uni-tuebingen.de
- Phone: +49 7071 29 80687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.