RecruitingPhase NA

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

Lead sponsor

University Hospital Tuebingen

Assets

GLP-1 / incretin class catch-all / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 18.5-24.9

Primary endpoint

•Cerebral response after insulin

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06487832

Org study ID065/2024BO1

Timeline

Milestones

Study start2024-07-01actual

Study first posted2024-07-05actual

Last update posted2025-03-30actual

Primary completion2027-07-31estimated

Study completion2027-12-31estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Semaglutide

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Patient-reported / QoL

Cardiometabolic biomarkers

Other clinical outcomes