- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00489229
To Investigate the Effect of Rosiglitazone and Ramipril on Pre-clinical Vasculopathy in Diabetes and IGT Patients
Studies on Diabetic and Pre Diabetic Vascular Disease and the Effect of Selected Therapeutic Modalities on Associated Vasculopathy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Kelantan
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Kota Bharu, Kelantan, Malaysia, 16150
- School of Medical Sciences, University Sains Malaysai
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measuring arterial stiffness (pulse wave velocity and augmentation index)
Time Frame: One year
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.
Time Frame: One year
|
One year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Abdul Rashid A Rahman, MRCP, PhD, Universiti Sains Malaysia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Hyperglycemia
- Vascular Diseases
- Glucose Intolerance
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin-Converting Enzyme Inhibitors
- Rosiglitazone
- Ramipril
Other Study ID Numbers
- ID: 305/PPSP/6112215
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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