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

Diabetes Clinical Trial

Official title:

Studies on Diabetic and Pre Diabetic Vascular Disease and the Effect of Selected Therapeutic Modalities on Associated Vasculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489229
• Other study ID #: ID: 305/PPSP/6112215
• Status: Completed
• Phase: Phase 3
• First received: June 20, 2007
• Last updated: July 15, 2009
• Start date: October 2002
• Est. completion date: December 2005

Study information

• Verified date: March 2007
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance
• Impaired Glucose Tolerance
• Vascular Diseases

Intervention

Drug:
• Rosiglitazone

• Ramipril

Locations

Country	Name	City	State
Malaysia	School of Medical Sciences, University Sains Malaysai	Kota Bharu	Kelantan

Sponsors (2)

Lead Sponsor	Collaborator
University of Science Malaysia	Ministry of Health, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring arterial stiffness (pulse wave velocity and augmentation index)		One year
Secondary	Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.		One year