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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT04490460
Eligibility Criteria:
Inclusion Criteria:
1. Between 18-80 years of age
2. BMI \< 45 kg/m2
3. Eligible based on a recent (within the past year) blood test meeting one of these specifications:
1. Fasting glucose of 100 to 125 mg/dl
2. Plasma glucose measured 2 hours after a 75-gram glucose load of 140 to 199 mg/dl
3. A1c of 5.7 to 6.4%
4. Clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy (may be self-reported)
4. Willing to comply with study requirements
5. Provide written informed consent
Exclusion Criteria:
1. Known diagnosis of diabetes / taking any medication for the treatment of diabetes including the off-label use of a GLP-1 receptor agonist, SGLT-2, or metformin) within the last 3 months for weight loss.
2. Active participation in another lifestyle or behavior change education or research program (DPP or weight loss program)
3. Current treatment with systemic corticosteroids (topical and nasal steroids are allowed)
4. Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
5. Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04490460
Study Brief:
Protocol Section:
NCT04490460