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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Pioglitazone and Rosiglitazone on Atherosclerotic and Inflammatory Markers in Patients With Metabolic Syndrome

NCT00314561

Metabolic Syndrome

COMPLETED PHASE4

Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes

NCT00772174

Diabetes Mellitus

COMPLETED PHASE3

Study of TNF-Antagonism in Metabolic Syndrome

NCT00409318

Metabolic Syndrome

COMPLETED NA

Effect of Rosiglitazone in Nondiabetic Patients With the Metabolic Syndrome

NCT00364221

Metabolic Syndrome Insulin Resistance

COMPLETED PHASE4

Efficacy and Safety of Pioglitazone and Azilsartan in Treating Subjects With Type 2 Diabetes Mellitus

NCT00762736

Diabetes Mellitus

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active control

1\. Active Control: (n=20), intervention: no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

PIO arm

PIO arm (n=30), Pioglitazone 30 mg/day, given for 24 weeks.

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

Tab. Pioglitazone-30 mg/day, oral, 24 weeks

Telmi arm

Telmia arm (n=30): Tab. Telmisartan 40 mg/day given for 2 weeks.

Group Type ACTIVE_COMPARATOR

Telmisartan

Intervention Type DRUG

Tab. Telmisartan- 40 mg/day, oral, 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pioglitazone

Tab. Pioglitazone-30 mg/day, oral, 24 weeks

Intervention Type DRUG

Telmisartan

Tab. Telmisartan- 40 mg/day, oral, 24 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No