Primary Prevention of Cardiovascular Disease (CVD) in Pre-diabetic & Pre-hypertensive Subjects

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to determine whether treating pre-diabetic \& pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.

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Detailed Description

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The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.

Conditions

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Pre-diabetes Pre-hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Metformin+Enalapril+Simvastatin

Group Type EXPERIMENTAL

Metformin+Enalapril+Simvastatin

Intervention Type DRUG

Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DRUG

Identical Placebo Tablet

Interventions

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Metformin+Enalapril+Simvastatin

Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years

Intervention Type DRUG

Placebo tablet

Identical Placebo Tablet

Intervention Type DRUG

Other Intervention Names

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Poly-pill Placebo

Eligibility Criteria

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Inclusion Criteria

* Pre-diabetes
* Pre-hypertensives
* LDL-Cholesterol \>= 100 \< 190 mg/dl
* BMI \>= 23
* Estimated GFR \>= 60 ml/min/1.73 m2 (MDRD equation)
* Willing to participate and provide written inform consent

Exclusion Criteria

* Current involved in other studied medications
* Regular use of corticosteroids
* Current use of weight loss medication
* History of renal disease
* Active liver disease including jaundice, chronic hepatitis with ALT \>= 2.5 the upper normal limit
* Active malignancy
* Major psychiatric disorder
* Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics)
* Nursing women, pregnant women, or those that plan to become pregnant in the study period

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes