Tests a GLP-1 drug's effect on brain insulin response in adults
Tests semaglutide against placebo on brain insulin response in adults.
Plain-language title generated from the registry record
Registry title: Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
Key facts
- Where
- Tübingen, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06487832, who can take part
Where in Germany
- University Clinic Tübingen, Department of Internal Medicine IVTübingen, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital Tuebingen
- Trial code
- NCT06487832
- Record updated
- 30 March 2025
- Original description
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.Read full original descriptionShow less
Impact of the Incretin System on Brain Insulin Sensitivity in Humans with Normal Weight, Overweight and Obesity
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.
Inclusion: 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: 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; 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; 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; Women of childbearing age who do not consent to take a pregnancy test; 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.