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Official title Effect of GLP1 Receptor Agonist on Brain Insulin Responsiveness
ClinicalTrials.gov ID: NCT06487832
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
- BMI \ 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
See the full eligibility 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
- Type 1 or type 2 diabetes, LADA, MODY, or cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
- BMI \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.