Investigating the impact of a GLP-1 medication on brain insulin response
Impact of the Incretin System on Brain Insulin Sensitivity in Humans with Normal Weight, Overweight and Obesity
This study is testing if a medication called semaglutide can change how the brain responds to insulin in people of different weights to see if it helps with thinking and eating habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT06487832 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how the GLP-1 receptor agonist semaglutide affects brain insulin responsiveness in participants with normal weight and those who are overweight or obese. It employs a randomized, single-blinded, within-subject crossover design, comparing the effects of semaglutide versus a placebo. Participants will undergo functional magnetic resonance imaging (fMRI) after receiving either intranasal insulin or placebo, while also performing tasks related to cognitive functions and eating behavior. The primary outcome is the brain's response to insulin, measured through cerebral blood flow and resting-state BOLD imaging, with secondary outcomes including cognitive and metabolic assessments.
Who should consider this trial
Good fit: Ideal candidates are healthy adults with a BMI between 18.5-24.9 kg/m2 or 27.5-40 kg/m2.
Not a fit: Patients with diabetes, significant cardiovascular diseases, or other chronic conditions affecting glucose metabolism are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of brain insulin responsiveness, potentially leading to improved treatments for obesity and insulin resistance.
How similar studies have performed: While studies on GLP-1 receptor agonists have shown promise in metabolic health, this specific investigation into brain insulin responsiveness is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI between 18.5 and 24.9 kg/m2; and between 27.5 kg/m2 and 40 kg/m2 * Written consent to participate in the study * Written consent to be informed about incidental findings Exclusion Criteria: * Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke * BMI \< 18.5 or \> 40 kg/m2 * Persons who cannot legally give consent * Pregnancy or lactation * History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures) * Taking psychotropic drugs * Chronic diseases or medication that influence glucose metabolism * Regular use of analgesic drugs * Previous bariatric surgery * Known allergy against one or more of the used agents * Acute infection and/or antibiotic treatment within the last 4 weeks * Hemoglobin values less than 10.5 g/dl for women, less than 11.5 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 * Participation in a lifestyle intervention study or a pharmaceutical study within the last 30 days * 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 * Persons with tinnitus * Weight loss or gain of \>5% in the last 3 months * Pancreatic diseases * History or family history of multiple endocrine neoplasia (MEN2) or medullary thyroid cancer * History of malignant thyroid disease * History of malignant disease in the past 5 years * Surgery in the last three months * Chronic tobacco use of more than 10 cigarettes/day * Women who do not consent to refrain from breastfeeding until 2 months after the end of the study * Women of childbearing age who do not consent to use safe method of contraception from 28 days before until 2 months after the end of the study or refrain from heterosexual intercourse during this time * Women of childbearing age who do not consent to take a pregnancy test
Where this trial is running
Tübingen
- University Clinic Tubingen, Department of Internal Medicine IV — Tübingen, Germany (Recruiting)
Study contacts
- Study coordinator: Stephanie Kullmann, PhD
- Email: stephanie.kullmann@med.uni-tuebingen.de
- Phone: 0049707129
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.