NCT06487832Recruiting
Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
Impact of the Incretin System on Brain Insulin Sensitivity in Humans with Normal Weight, Overweight and Obesity
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Jun 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Obesity
- NCT number
- NCT06487832
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Jul 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking psychotropic drugs
- Regular use of analgesic drugs
- Previous bariatric surgery
- Surgery in the last three months
- 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
Other illness
- Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
- History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures)
- Known allergy against one or more of the used agents
- Acute infection and/or antibiotic treatment within the last 4 weeks
- Other diseases that in the opinion of the investigator may jeopardize the success of the study or indicate a risk to the volunteer
- 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
- 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
Lab values
- Chronic diseases or medication that influence glucose metabolism
- Hemoglobin values less than 10.5 g/dl for women, less than 11.5 g/dl for men
Age
- Women of childbearing age who do not consent to take a pregnancy test
Other
- BMI \< 18.5 or \> 40 kg/m2
- Persons who cannot legally give consent
- Pregnancy or lactation
- Participation in a lifestyle intervention study or a pharmaceutical study within the last 30 days
- Persons with claustrophobia
- Persons with tinnitus
- Weight loss or gain of \>5% in the last 3 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinic Tübingen, Department of Internal Medicine IV Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.