Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called semaglutide, which acts on a hormone known as GLP-1, affects the way the brain responds to insulin. Insulin is a hormone that helps control blood sugar levels, and understanding how it works in the brain could be important for people who are overweight or have insulin sensitivity issues. The researchers will compare the effects of semaglutide to a placebo (a substance with no active medication) to see how each influences brain insulin response during imaging tests.

To participate in this study, individuals should be between the ages of 18 and 74, have a body mass index (BMI) in specific ranges (either normal weight or overweight), and be able to give written consent. There are several health conditions that would prevent someone from joining, such as having diabetes, certain heart diseases, or a history of severe mental disorders. If chosen, participants will receive either the semaglutide or placebo and will undergo brain scans to measure insulin response, helping researchers learn more about the relationship between this medication and brain function. It’s a great opportunity for individuals who meet the criteria and are interested in contributing to important health research.

Gender

ALL

Eligibility criteria

• 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