RecruitingNot Applicable

Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

Germany60 participantsStarted 2024-07-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cerebral response after insulin compared to placebo nasal spray

Timeframe: 24 hours after semaglutide or placebo administration

Trial details

NCT IDNCT06487832

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Stephanie Kullmann, PhD

0049707129 stephanie.kullmann@med.uni-tuebingen.de

View on ClinicalTrials.gov More Normal Weight trials