Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT06487832
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06487832
Study Brief:
Protocol Section:
NCT06487832