NCT00926341

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2009

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

1.7 years

First QC Date

June 22, 2009

Last Update Submit

June 23, 2009

Conditions

Metabolic Syndrome

Keywords

Metabolic syndromeinflammatory markersThiazolidinedionesAngiotensin receptor blockers

Outcome Measures

Primary Outcomes (1)

  • Control of blood pressure and decline in triglycerides level

    24 weeks

Secondary Outcomes (1)

  • Improvement in Inflammatory markers Hs-CRP, TNF-alpha, IL-6 and visceral obesity

    24 weeks

Study Arms (3)

Active control

NO INTERVENTION

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

PIO arm

ACTIVE COMPARATOR

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

Drug: Pioglitazone

Telmi arm

ACTIVE COMPARATOR

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

Drug: Telmisartan

Interventions

PioglitazoneDRUG

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

PIO arm
TelmisartanDRUG

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

Telmi arm

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, J.N.Medical,College, AMU,Aligarh

Aligarh, Uttar Pradesh, 202002, India

Location

Related Publications (1)

  • Szapary PO, Bloedon LT, Samaha FF, Duffy D, Wolfe ML, Soffer D, Reilly MP, Chittams J, Rader DJ. Effects of pioglitazone on lipoproteins, inflammatory markers, and adipokines in nondiabetic patients with metabolic syndrome. Arterioscler Thromb Vasc Biol. 2006 Jan;26(1):182-8. doi: 10.1161/01.ATV.0000195790.24531.4f. Epub 2005 Nov 10.

    PMID: 16284192BACKGROUND

Related Links

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

PioglitazoneTelmisartan

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Shahzad F HAQUE, MBBS.MD

    Department of medicine,JNMC, AMU, ALIGARH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 23, 2009

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

IN(1)