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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT02680457
Eligibility Criteria:
Inclusion Criteria:
* Patients with T2DM without treatment for at least 3 months Body mass index (BMI) from 25.0-34.9 kg/m2 Diagnosis of T2DM
* Fasting plasma glucose ≤300 mg/dL at the time of scrutiny
* A1C between 6.5 and 11%
* Written informed consent
Exclusion Criteria:
* Women pregnant or breastfeeding
* Untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\]
* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose. In the case of antihypertensives, these may be included if treatment was not modified previous 3 months and no change during the study.
* Total cholesterol \>240 mg/dL
* Triglycerides ≥400 mg/dL
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) more than twice the normal range
* Glomerular filtration rate \<60 mL/min \[Cockcroft-Gault\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
65 Years
Study:
NCT02680457
Study Brief:
Protocol Section:
NCT02680457