Actively Recruiting
Impact of the Incretin System on Brain Insulin Sensitivity in Adults with Normal Weight, Overweight, and Obesity
Led by University Hospital Tuebingen · Updated on 2025-03-30
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a GLP-1 receptor agonist called semaglutide on brain insulin responsiveness in healthy adults with normal weight, overweight, or obesity. This randomized, single-blinded, crossover study compares semaglutide with a placebo to understand how these treatments affect brain responses to insulin. The main goal is to observe changes in cerebral blood flow and brain activity related to insulin using functional MRI imaging. Participants receive an acute dose of 0.25 mg semaglutide or a saline placebo by subcutaneous injection. After 24 hours, they undergo functional MRI scans paired with intranasal insulin or placebo administration. The study also assesses cognitive function and eating behavior during these visits. The trial includes both male and female adults aged 18 to 70 and allows participants to serve as their own controls by crossing over between treatments. Throughout the study, participants complete brain imaging sessions, cognitive tests, and questionnaires about hunger, food cravings, and mood. Researchers measure brain responses to insulin, neural reactions to food cues, heart rate variability, and diffusion-weighted imaging changes. Safety and health are monitored, including screening for infections, recent surgeries, and medication use. The study aims to provide insights into brain insulin sensitivity influenced by GLP-1 receptor activation over the trial period.
CONDITIONS
Brief Title
Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18.5 and 24.9 kg/m2 or between 27.5 and 40 kg/m2
- Written consent to participate in the study
- Written consent to be informed about incidental findings
You will not qualify if you...
- Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, or stroke
- BMI less than 18.5 or greater than 40 kg/m2
- Persons who cannot legally give consent
- Pregnancy or lactation
- History of severe mental or somatic disorders including neurological diseases such as epileptic seizures
- Taking psychotropic drugs
- Chronic diseases or medication that influence glucose metabolism
- Regular use of analgesic drugs
- Previous bariatric surgery
- Known allergy to any study agents
- Acute infection or antibiotic treatment within the last 4 weeks
- Low hemoglobin values (less than 10.5 g/dl for women, less than 11.5 g/dl for men)
- Other diseases judged by the investigator to pose risk or affect study success
- Participation in another lifestyle or pharmaceutical study within the last 30 days
- Metal implants that cannot be removed, including pacemakers, artificial heart valves, insulin pumps, large tattoos, retainers over more than 4 teeth, contraceptive coils, or implanted magnetic metal parts
- Claustrophobia
- Tinnitus
- Weight change greater than 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 or other malignant diseases within the past 5 years
- Surgery within the last 3 months
- Chronic tobacco use of more than 10 cigarettes per day
- Women who do not agree to avoid breastfeeding until 2 months after study end
- Women of childbearing age who do not agree to use safe contraception from 28 days before until 2 months after study end or to avoid heterosexual intercourse during this time
- Women of childbearing age who do not agree to take a pregnancy test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two treatment periods with a washout interval (duration not specified)
Participants receive a single acute subcutaneous administration of either 0.25 mg semaglutide or placebo in a crossover design. Brain insulin responsiveness and cognitive functions are assessed using functional MRI and other tests 24 hours after each administration.
2 visits (in-person), one for each treatment administration and assessment
Trial Site Locations
Total: 1 location
1
University Clinic Tubingen, Department of Internal Medicine IV
Tübingen, Germany, 72076
Actively Recruiting
Research Team
S
Stephanie Kullmann, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here