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

Mahidol University

Status

Unknown

Conditions

Pre-diabetes

Pre-hypertension

Treatments

Drug: Metformin+Enalapril+Simvastatin

Drug: Placebo tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT01364675

12011

Details and patient eligibility

About

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.

Full description

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.

Enrollment

8,900 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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