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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT01942694
Eligibility Criteria:
Inclusion Criteria:
1. Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit:
1. Fasting plasma glucose (FPG) 100-125 mg/dL
2. 2-hour plasma glucose (2hPG) 140-199 mg/dL
3. Hemoglobin A1c (HbA1c) 5.7-6.4%
2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).
3. Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2
4. Provision of signed and dated written informed consent prior to any study procedures.
Major Exclusion Criteria:
1. Diabetes based on either of the following criteria:
1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome.
2. Meeting the diagnosis criteria for diabetes
2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.
3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
4. Currently breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01942694
Study Brief:
Protocol Section:
NCT01942694