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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03896360
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects who are 21 years of age or older
* BMI 25-40 kg/m2
* Pre-diabetes defined by an HbA1c of 5.7-6.4%
* Weight stable (\< 5% body weight change over preceding 6 months)
* Provide valid informed consent
Exclusion Criteria:
* Previous diagnosis of T2DM or Hb1A1c greater than or equal to 6.5% or fasting glucose \> 125mg/dl on screening or 2 hour glucose greater than or equal to 200 mg/dl on OGTT
* Patients who are on any oral/ injectable medications used to treat diabetes including metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 analogs, SGLT2 inhibitors, glitazones and insulin
* Patients on over the counter or approved weight loss medications
* Pregnant or lactating females
* Previous bariatric surgery
* Psychotropic and/or other medications known to significantly impact weight unless on stable dose for 6 months
* eGFR \< 45ml/min
* Significant hepatic, cardiac, gastrointestinal, neurologic or other medical illness that would preclude participation in the study
* Untreated hypothyroidism or other endocrine disorders
* Non-English speaking patients
* Any patient deemed unsuitable in the investigator's opinion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03896360
Study Brief:
Protocol Section:
NCT03896360