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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT06374368
Eligibility Criteria:
Inclusion Criteria:
* age 18-65 years at screening;
* Body mass index ≥30 or ≤50kg/m2;
* If subject has Type 2 Diabetes: fasting plasma glucose greater than 6,1 mmol/l at time of enrollment if not treated with anti-diabetic medication;
* If on no diabetes medications, Hemoglobin A1C between and including 6.5 and 9.0 at time of enrollment.
Exclusion Criteria:
* Body Mass Index \>50 or \<30 kg/m2;
* Diagnosis of Type 2 diabetes less than 6 months;
* History of suspected gastrointestinal disease (for example cirrhosis, inflammatory bowel disease);
* History of active malignancy (not in remission) with the exception of squamous or basal cell carcinoma of the skin;
* Ongoing systemic infection;
* Chronic pancreatitis;
* Chronic liver disease of any cause;
* Poorly controlled psychiatric disease (for example ongoing major depression, schizophrenia, borderline personality, suicidality, psychosis);
* Any history of an eating disorder within the past 5 years;
* Pre-existing severe comorbid cardio-respiratory disease (for example congestive heart failure, cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease, pulmonary embolism);
* uncontrolled hypertension (systolic Blood Preassure \> 150 mm Hg or diastolic Blood Preassure \> 100 mm Hg).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06374368
Study Brief:
Protocol Section:
NCT06374368