The Effects of Peroxisome Proliferators Activated Receptor-Gamma (PPAR-γ) Agonists on Certain Biochemical and Inflammatory Markers in Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT00926341|
Recruitment Status : Completed
First Posted : June 23, 2009
Last Update Posted : June 24, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Drug: Pioglitazone Drug: Telmisartan||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study on the Effects of Peroxisome Proliferators Activated Receptor-γ Agonists on Certain Biochemical and Inflammatory Markers in Patients With Metabolic Syndrome|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||September 2008|
U.S. FDA Resources
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.
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.
Tab. Telmisartan- 40 mg/day, oral, 24 weeks
- Control of blood pressure and decline in triglycerides level [ Time Frame: 24 weeks ]
- Improvement in Inflammatory markers Hs-CRP, TNF-alpha, IL-6 and visceral obesity [ Time Frame: 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926341
|Department of Medicine, J.N.Medical,College, AMU,Aligarh|
|Aligarh, Uttar Pradesh, India, 202002|
|Principal Investigator:||Shahzad F HAQUE, MBBS.MD||Department of medicine,JNMC, AMU, ALIGARH|