Investigating the impact of a GLP-1 medication on brain insulin response

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating the best time for resistance exercise to improve insulin sensitivity and sleep

  This study is testing whether doing resistance exercises in the morning or evening helps people aged 50-74 with overweight or obesity improve their insulin sensitivity and sleep quality.

  Recruiting University of Utah · Salt Lake City, Utah · NCT06366399

• Investigating insulin resistance using alpelisib in adults

  This study is testing if a drug called alpelisib can help us understand how insulin works in healthy adults compared to those at risk for type 2 diabetes.

  Recruiting Phase 1 Columbia University · New York, New York · NCT06354088

• Increasing sleep duration to improve health in people with obesity

  This study is testing if getting an extra 2 hours of sleep each night can help people with obesity improve their health and insulin sensitivity.

  Recruiting University of Utah · Salt Lake City, Utah · NCT06180837

• Endoscopic sleeve gastroplasty for people with obesity and MASH

  This study will test whether endoscopic sleeve gastroplasty plus lifestyle changes helps adults with obesity and MASH lose weight and improve liver health compared with lifestyle changes alone.

  Recruiting at 2 sites Brigham and Women's Hospital · Boston, Massachusetts and 1 other locations · NCT06138821

• Impact of weight loss on fat tissue signaling in muscles

  This study is testing how losing weight affects fat tissue in muscles and whether it helps people with obesity improve their insulin sensitivity.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT06129110

• Improving cardiometabolic health through circadian interventions

  This study is testing whether changing sleep habits and reducing nighttime light and eating can help people with overweight and obesity who don’t get enough sleep improve their health over eight weeks.

  Recruiting University of Utah · Salt Lake City, Utah · NCT05943626

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.