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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02972567
Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of insulin resistance syndrome, according to Criteria of the International Diabetes Federation (IDF)
* BMI\>30 kg/m2 or Waist Circumference ≥ 94cm (men) WC≥ 80cm (women)
* Serum Triglycerides ≥ 150 mg/dl
* HDLcholesterol \< 40 mg/dl (1,03 mmol/l) in men and \< 50 mg/dl (1,29 mmol/l) in women
* Systolic blood pressure ≥ 130 mmHg or diastolic ≥ 85 mmHg
* Glucose ≥ 100 mg/dl (5,6 mmol/l) (not previous diagnostic of diabetes II)
Exclusion Criteria:
* Patients with renal or hepatic impairment
* Patients with a diagnosis of diabetes
* Patients with diseases that condition immunosuppression
* Patients presenting positive serologies for liver viruses
* Being on antihypertensive treatment: beta-blockers, Angiotensin 2 receptor antagonists (ARA 2), enzyme inhibitors, Angiotensin converting enzyme (ACE) inhibitors.
* Patients receiving lipid-lowering and / or hypoglycemic agents
* Patients on treatment with drugs that increase hepatic enzymes,such as Amiodarone, perhexiline, maleate and 4,4'-diethylaminoethoxyhexestrol, synthetic estrogens, Tamoxifen, corticosteroids, acetylsalicylic acid, Valproic acid, tetracyclines, viral agents (zidovudine, zalcitabine, didanosine), among others.
* Exhibiting high values of C-reactive protein (CRP) or Sedimentation (ESR)
* Consuming alcohol in quantities greater than 40 g / d or other hepatotoxic.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02972567
Study Brief:
Protocol Section:
NCT02972567