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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT02708966
Eligibility Criteria:
Inclusion Criteria:
* BMI: 25.0-34.99 kg / m2.
* Diagnosis of IGT (2h-OGTT Values between 140mg / dl and 199mg / dl.)
* Written informed consent.
* body weight stable over the last 3 months.
* Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
* Women who are not contemplated get pregnant within the next 6 months.
Exclusion Criteria:
* Women pregnant or breastfeeding.
* Physical or mental disability that makes it impossible to perform the intervention.
* Diagnosis of hypertension or heart failure.
* Smokers.
* Untreated thyroid disease.
* Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
* Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
* Diagnosis of renal disease or creatinine \> 1.5 mg / dl.
* Diagnosis of Type 2 Diabetes Mellitus (T2DM) Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg / dL and/or A1C ≥ 6.5%.
* Total Cholesterol ≥ 280 mg/dL.
* Triglycerides ≥ 300 mg/dL.
* Known allergy to calcined magnesia or Gymnema sylvestre.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
59 Years
Study:
NCT02708966
Study Brief:
Protocol Section:
NCT02708966