The Effects of Peroxisome Proliferators Activated Receptor-Gamma (PPAR-γ) Agonists on Certain Biochemical and Inflammatory Markers in Metabolic Syndrome

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 public health problem for South Asians in their homeland and worldwide.

Pharmacological therapy is a critical step in the management of patients with metabolic syndrome. In general, treatment for metabolic syndrome, that targets all or most of the components of metabolic syndrome is either deficient or non-existent. The study presented here is the pioneering work in the management of metabolic syndrome, the emerging global epidemic.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aligarh Muslim University
• Treatments: Pioglitazone; Telmisartan

Criteria

Inclusion Criteria:

• Patients with at least 3 out of 5 criteria of metabolic syndrome of NCEP-ATP III (Asian-Pacific) guideline:

1. Waist circumference of > 90 cm in men or > 80 cm in women;

2. Serum triglycerides of >= 150 mg/dl;

3. High-density lipoprotein-cholesterol (HDL-C) levels of < 40 mg/dl in men and < 50 mg/dl in women;

4. Fasting glucose of 6.1/ m.mol (≥l00 mg/dl)

5. 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 Criteria:

• 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.