Status:
COMPLETED
The Effects of Peroxisome Proliferators Activated Receptor-Gamma (PPAR-γ) Agonists on Certain Biochemical and Inflammatory Markers in Metabolic Syndrome
Lead Sponsor:
Aligarh Muslim University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
Metabolic syndrome, labeled as the world's latest epidemic, is the force behind the global epidemic of Type 2 Diabetes Mellitus and Cardio Vascular Diseases. This emerging epidemic is an important pub...
Detailed Description
Our understanding of the metabolic syndrome has been improved by the discovery nuclear peroxisome proliferator-activated receptors (PPARs). PPAR-γ is a nuclear receptor that influences the expression ...
Eligibility Criteria
Inclusion
- Patients with at least 3 out of 5 criteria of metabolic syndrome of NCEP-ATP III (Asian-Pacific) guideline:
- Waist circumference of \> 90 cm in men or \> 80 cm in women;
- Serum triglycerides of \>= 150 mg/dl;
- High-density lipoprotein-cholesterol (HDL-C) levels of \< 40 mg/dl in men and \< 50 mg/dl in women;
- Fasting glucose of 6.1/ m.mol (≥l00 mg/dl)
- Systolic blood pressure \> = 130 mmHg or Diastolic blood pressure \>= 85 mmHg or OR on anti-hypertensive therapy
- Ability to perform all tasks related to glycemic control and risk factor management.
- Written informed consent.
- Between 30 and 70 years of age of either sex.
Exclusion
- Concomitant use of ACE inhibitor or ARB in the last 3 months. Or angioedema with ACE I / ARB or uncontrolled hypertension (SBP \>=160 mmHg and/or DBP \>=100 mmHg) or known case of secondary hypertension.
- Patients already taking any thiazolidinediones or having contraindications for the same.
- Class III or IV heart failure
- Renal dysfunction as defined by serum creatinine \> 130umol/L (\> 2.0 mg/dl)
- Concomitant use of statin or fenofibrate.
- Hepatic dysfunction as defined by SGPT (ALT)\> 3 times the upper limit of normal
- Taking Anti-obesity medications/metformin
- History of drug or alcohol dependency within six months.
- History of active malignancy, chronic,inflammatory disorder, or chronic infections which would interfere with protocol completion.
- Use of systemic glucocorticosteroids/aspirin/anti-inflammatory drugs.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00926341
Start Date
October 1 2006
End Date
September 1 2008
Last Update
June 24 2009
Active Locations (1)
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1
Department of Medicine, J.N.Medical,College, AMU,Aligarh
Aligarh, Uttar Pradesh, India, 202002