Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Normal Weight, Overweight and Obesity, Insulin Sensitivity, Insulin Resistance
In brief
The overarching goal of the current study is to investigate the effect of GLP-1 on brain insulin responsiveness in a randomized, single-blinded, within subject cross-over study design. To this end, investigators will compare the effect of the administration of semaglutide versus placebo, followed by an fMRI with administration of intranasal insulin or placebo.
Key facts
- Study ID
- NCT06487832
- Run by
- University Hospital Tuebingen
- People needed
- 60
- Starts
- 2024-07-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-03-30
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Clinic Tubingen, Department of Internal Medicine IV — Tübingen, Germany (enrolling)
Full record on ClinicalTrials.gov
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