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

June 23, 2009 updated by: Aligarh Muslim University

A Study on the Effects of Peroxisome Proliferators Activated Receptor-γ Agonists on Certain Biochemical and Inflammatory Markers in Patients With Metabolic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 of multiples gene involved in carbohydrate and lipid metabolism. At the crossroads of obesity, insulin resistance, and cardiovascular disease is the nuclear receptor PPAR-γ. At present, metabolic syndrome can be described as a 'PPAR-γ agonist resistance syndrome.' The modulation of PPAR-gamma activity is an interesting therapeutic approach to address multi-component metabolic syndrome and its consequent cardiovascular events.

Recent studies have indicated that in addition to anti diabetic properties, PPAR-γ agonists (TZD)-Pioglitazone, provides protection against atherosclerotic cardiovascular disease. Further, the identification of ARBs-Telmisartan and Irbesartan, as capable of activating PPAR - γ, has provided a novel approach in treating hypertension, insulin resistance, hyperlipidemia, and inflammation.

Emerging evidence suggests that PPAR-γ agonist: Thiazolidinediones (TZD)-Pioglitazone is an insulin sensitizer and modulator of metabolic syndrome, through its pleiotropic effects on vascular risk and have beneficial effects on systemic inflammatory markers. Despite the beneficial effects of full PPAR- agonists like the TZDs, recent evidence suggests that full PPAR- agonists are less than optimal agents in patients with metabolic syndrome. TZDs promote adipo-genesis and fluid retention, causing weight gain and precipitate congestive heart failure. The adverse effects of full PPAR- agonists like the TZDs have reinforced the need to identify additional therapies with insulin-sensitizing properties. The recent discovery that telmisartan, an angiotensin II type 1 receptor (AT1-R) blockers (ARBs), is uniquely capable of selective PPAR- -modulating activities, have the potential to treat both hemodynamic and biochemical features of insulin resistance and metabolic Syndrome.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttar Pradesh
      • Aligarh, Uttar Pradesh, India, 202002
        • Department of Medicine, J.N.Medical,College, AMU,Aligarh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Active control
1. Active Control: (n=20), intervention: no intervention
ACTIVE_COMPARATOR: PIO arm
PIO arm (n=30), Pioglitazone 30 mg/day, given for 24 weeks.
Drug: Pioglitazone
Tab. Pioglitazone-30 mg/day, oral, 24 weeks
ACTIVE_COMPARATOR: Telmi arm
Telmia arm (n=30): Tab. Telmisartan 40 mg/day given for 2 weeks.
Drug: Telmisartan
Tab. Telmisartan- 40 mg/day, oral, 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Control of blood pressure and decline in triglycerides level
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in Inflammatory markers Hs-CRP, TNF-alpha, IL-6 and visceral obesity
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aligarh Muslim University

Investigators

  • Principal Investigator: Shahzad F HAQUE, MBBS.MD, Department of medicine,JNMC, AMU, ALIGARH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

June 22, 2009

First Submitted That Met QC Criteria

June 22, 2009

First Posted (ESTIMATE)

June 23, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 24, 2009

Last Update Submitted That Met QC Criteria

June 23, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFH-CASR-FMD-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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