Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness (NCT06487832) | Clinical Trial Compass
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 range18 Years – 70 Years
SexALL
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 …
What they're measuring
1
Cerebral response after insulin compared to placebo nasal spray
Timeframe: 24 hours after semaglutide or placebo administration