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 @ 3:23 AM
Ignite Modification Date:
2025-12-25 @ 3:23 AM
NCT ID:
NCT03541005
Eligibility Criteria:
Inclusion Criteria:
* Patients who fulfill the diagnosis criteria of overweight or obesity (BMI ≥ 25.0 and less than 40).
* Age between 20 and 65 years old.
* Values of fasting glucose \< 7.0 mmol / L and at two hours \< 11.1 mmol / L during Glucose Tolerance Test (OGTT).
* Written informed consent of participation in the study.
Exclusion Criteria:
* Thyroid dysfunction (hypo or hyperthyroidism).
* Type 1 or type 2 diabetes.
* Prediabetes treated with oral agents.
* Alterations of lipids treated with drugs.
* Medicine consumption of or dietary supplements that influence the reduction of body weight.
* Consumption of steroids or prolonged use of them (last 3 months).
* Treatment with immunosuppressive drugs.
* Chronic diseases (of the hepatic, renal and cardiovascular systems, pancreatitis or some type of malignancy condition) or acute at the time of inclusion.
* Insulin resistance due to diseases such as acromegaly, endogenous hypercortisolism, polycystic ovarian syndrome or hyperprolactinemia.
* History of symptomatic hypoglycaemia.
* History of chronic debilitating diseases, anemia and collagen diseases.
* History or existence psychological illness with eating disorders or toxicity.
* History of alcoholism or drug dependence.
* Inability to comply with the instructions of the investigation.
* Severe infections at the time of inclusion.
* Women of childbearing age who use hormonal contraceptives (oral or injectable).
* Pregnant or breastfeeding.
* Known sensitivity to any of the components of the formulation
* Gynoid fat distribution.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT03541005
Study Brief:
Protocol Section:
NCT03541005