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:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
NCT ID:
NCT03610412
Eligibility Criteria:
Inclusion Criteria:
* Signature of consent under written information prior to the completion of any procedure in the study.
* Men and women aged 40 to 59 years old, residents of Guadalajara, Jalisco and the metropolitan area.
* Ability to communicate and meet all the requirements of the study.
* BMI less than or equal to 34.9 kg / m2.
* Diagnosis of DM2 according to the ADA:
* Plasmatic glucose ≥126mg / dl (7.0 mmol / L) in an 8-hour fast.
* Plasmatic glucose ≥200mg / dl (11.1 mmol / L) at 2 hours after an oral glucose tolerance test.
or HbA1C ≥6.5% (48 mmol / mol).
o Plasmatic glucose ≥200mg / dl (11.1 mmol / L) in a random sample to the patient with classic symptoms of hyperglycemia.
* Evolution of DM2 less than 1 year.
* Be receiving pharmacological treatment with metformin in doses less than or equal to 850mg.
* Stable body weight within 3 months prior to the start of the study, defined as a variability in body weight of less than 10%.
* Eumenorrheic women with mechanical or definitive contraceptive method without hormonal treatment.
Exclusion Criteria:
* Determination of HbA1c less than 6.5%, greater than 10% or fasting glucose greater than 250 mg / dL.
* Serum total cholesterol concentration greater than or equal to 240mg / dl.
* Serum triglyceride concentration greater than or equal to 400mg / dl.
* History of hypersensitivity to study drugs.
* Intake of drugs with known effects on glucose metabolism, lipids, and weight.
* Uncontrolled arterial hypertension, defined as systolic blood pressure values greater than or equal to 140mm / Hg and a diastolic blood pressure greater than or equal to 90mm / Hg.
* History of cardiovascular disease, blood disorders, kidney, pancreatic or thyroid disease.
* Women with suspicion or confirmation of pregnancy
* Women in breastfeeding period.
* History of smoking at any intensity within 12 months prior to the start of the study.
* History of drug abuse or alcoholism.
* Inability to attend or answer the evaluations made in each of the visits.
* Pacemaker bearing, or any other permanent bioelectronic element that can modify the electric bioimpedance reading or be affected by it.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
59 Years
Study:
NCT03610412
Study Brief:
Protocol Section:
NCT03610412