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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT00573950
Eligibility Criteria:
* Eligible for study: 18 year and above, Gender eligible for study: both Inclusion Criteria:Type 2 diabetes patients with metabolic syndrome criteria of Asian-Pacific ATP III guideline
* Type 2 diabetes (at least 1 criteria below)
1. fasting blood glucose ≥ 126 mg/dL
2. postprandial 2hour glucose ≥ 200 mg/dL
3. random blood glucose ≥ 200 mg/dL with typical diabetes symptoms
* Metabolic syndrome : Asian-Pacific ATP III guideline
1. Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes
2. systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension
3. Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality
4. HDL-cholesterol \< 40 mg/dL for men and \< 50 mg/dL for women, or Specific treatment for this lipid abnormality
5. Waist circumference ≥ 90 for men and ≥ 80 for women
Exclusion Criteria:
* Hypertensive patients with the use of ACE inhibitor or ARB
* Hyperlipidemic patients with the use of statin or fenofibrate
* Hepatic dysfunction
* Chronic alcohol or drug abuse
* Renal dysfunction
* Heart failure
* Patients who takes hormone replace therapy or steroid containing drugs
* Patients who take drugs like anticoagulant (warfarin), anti-platelet agent (aspirin, ticlopidin), thrombolytic agent (urikinase, alteplase), prostaglandine E1 , drugs inhibit CYP3A4 or CYP2C19, or drugs become substrate of CYP3A4
* Patients who haves disease influencing the results of the study such as neurologic, digestive and neoplastic disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00573950
Study Brief:
Protocol Section:
NCT00573950