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

Not Applicable

• Conditions: Pre-diabetes; Pre-hypertension
• Interventions: Drug: Metformin+Enalapril+Simvastatin; Drug: Placebo tablet

• Registration Number: NCT01364675
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2011-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-01
• Last Update Submitted: 2011-06-01
• Study First Posted: 2011-06-02
• Last Update Posted: 2011-06-02
• Study Start: 2012-01
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8900

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin+Enalapril+Simvastatin	Metformin+Enalapril+Simvastatin	-
Placebo tablet	Placebo tablet	-

Primary Outcome Measures

Name	Time	Method
Cardiovascular Events	4-year	Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause)

Secondary Outcome Measures

Name	Time	Method
Micro-vascular Complications	4-year	Renal dysfunction, ESRD (on dialysis or kidney transplantation), Progression of Albuminuria, Retinopathy
Cumulative Incidence of Diabetes	4-year
Cumulative Incidence of Hypertension	4-year
Incidence of Individual Cardiovascular Disease	4-year	Coronary Artery Disease - Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization; Stroke- Cerebral Hemorrhage, Cerebral Infarction, Subarachnoid Hemorrhage; Peripheral Artery Disease- Leg amputation, endovascular or surgical intervention in leg arteries

Trial Locations

Locations (1)

Ubon ratchathani Public Health Office; 🇹🇭 Muang District, Ubon ratchathani, Thailand