To Investigate the Effect of Rosiglitazone and Ramipril on Pre-clinical Vasculopathy in Diabetes and IGT Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00489229
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : July 16, 2009
Ministry of Health, Malaysia
Information provided by:
University of Science Malaysia

Brief Summary:
The aim is to examine whether pharmacological interventions with thiazolidinedione and angiotensin converting enzyme (ACE) inhibitors can reverse pre-clinical vasculopathy in newly diagnosed diabetic and IGT individuals.

Condition or disease Intervention/treatment Phase
Diabetes Impaired Glucose Tolerance Drug: Rosiglitazone Drug: Ramipril Phase 3

Detailed Description:

The burden of diabetic vasculopathy on the global population is enormous and ever growing. Besides the well-known microvascular complications in type 2 diabetes (T2DM), there is a growing epidemic of macrovascular complications. People with T2DM have a higher risk of death from cardiovascular (CV) diseases than persons without diabetes. Like diabetes, impaired glucose tolerance (IGT) individuals also have associated risk of developing macrovascular complications. This calls for an early detection and intervention in patients with T2DM as well as IGT, not only to delay progression of IGT to T2DM but also to treat early macrovascular diseases in both groups. The traditional therapeutic approaches of T2DM emphasise on glycaemic control, which limits microvascular diseases but lacks an established benefit in macrovascular diseases. Type 2 diabetes is a metabolic disorder characterised by dyslipidaemia, hypertension, and hypercoagulability in addition to hyperglycaemia and hyperinsulinaemia. Each of these abnormalities plays an important role in diabetic vasculopathy and provides targets for therapy. Understanding the mechanisms of diabetic vasculopathy and instituting therapy guided by emerging evidences would improve outcomes in patients with T2DM and IGT.

In recent years, special attention has been devoted to both thiazolidinediones (TZDs) and angiotensin converting enzyme (ACE) inhibitors when TRIPOD study demonstrated that troglitazone may reduce the rate of progression to diabetes in women diagnosed with gestational diabetes and HOPE Study showed that ramipril may delay the onset of diabetes. The TZDs are novel insulin-sensitising antidiabetic agents, which also have vasculoprotective properties. Rosiglitazone, one of the members of TZD family, improves insulin sensitivity and may have a beta cell cytoprotective effect. The ACE inhibitors reduce both microvascular and macrovascular complications in diabetes and appear to improve insulin sensitivity and glucose metabolism. Ramipril, an ACE inhibitor, has direct effects on the renin-angiotensin-kallikrein system and may play an important role in the prevention of diabetes through effects on beta cell and by vascular and metabolic effects on muscle that may amplify the effects of insulin. Previous studies showed that newly diagnosed untreated T2DM/IGT and hypertensive Malay patients had early manifestations of preclinical vasculopathy and potentially increased risk for development of macrovascular diseases. The aim of this study is to investigate whether pharmacological interventions with rosiglitazone and ramipril can reverse pre-clinical vasculopathy in newly diagnosed untreated T2DM and IGT patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Studies on Diabetic and Pre Diabetic Vascular Disease and the Effect of Selected Therapeutic Modalities on Associated Vasculopathy
Study Start Date : October 2002
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Measuring arterial stiffness (pulse wave velocity and augmentation index) [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level. [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Newly diagnosed untreated T2DM patients
  • Newly diagnosed untreated IGT patients
  • Normoglycaemic individuals
  • Age: 30-65 years
  • Blood Pressure <140/90 mmHg.

Exclusion Criteria:

  • Patients with T2DM
  • Hypertension (>140/90 mmHg)
  • Microvascular and/or macrovascular complications of diabetes
  • Severe hyperlipidaemia (>7.8 mmol/L)
  • Smokers
  • Obese people (BMI>30 Kg/m2)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00489229

School of Medical Sciences, University Sains Malaysai
Kota Bharu, Kelantan, Malaysia, 16150
Sponsors and Collaborators
University of Science Malaysia
Ministry of Health, Malaysia
Study Director: Abdul Rashid A Rahman, MRCP, PhD University of Science Malaysia

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00489229     History of Changes
Other Study ID Numbers: ID: 305/PPSP/6112215
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: July 16, 2009
Last Verified: March 2007

Keywords provided by University of Science Malaysia:
Impaired glucose tolerance
Arterial stiffness
Diabetic vasculopathy

Additional relevant MeSH terms:
Glucose Intolerance
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents