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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT06000735
Eligibility Criteria:
Inclusion Criteria (Must meet at least one of the following):
* Overweight and/or obese BMI classification, 25 to 35 kg/m2
* Fasting serum glucose ≥100 mg/dL and \<126 mg/dL or HbA1c \>5.7% and \< 6.5%
* Family history of Type 2 DM
* History of hypertension, hypertriglyceridemia, heart disease, and/or stroke
* History of gestational diabetes
Exclusion Criteria:
* Any subject currently taking blood thinning medications such as Warfarin or Coumadin
* Any history of gastrointestinal disease or surgery except for appendectomy or cholecystectomy.
* History of gastrointestinal surgery, diabetes mellitus, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP \>160mmHg, diastolic BP \>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, laxative abuse, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history.
* Pregnant or breastfeeding
* Currently uses tobacco products.
* Currently has an alcohol intake \> 20 g ⁄ day;
* Currently has a coffee intake \> 3 cups ⁄ day;
* Is unable or unwilling to comply with the study protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06000735
Study Brief:
Protocol Section:
NCT06000735