To Investigate the Effect of Rosiglitazone and Ramipril on Pre-clinical Vasculopathy in Diabetes and IGT Patients
Primary Purpose
Diabetes, Impaired Glucose Tolerance
Status
Completed
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Rosiglitazone
Ramipril
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Rosiglitazone, Ramipril, Impaired glucose tolerance, Arterial stiffness, Diabetic vasculopathy
Eligibility Criteria
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)
Sites / Locations
- School of Medical Sciences, University Sains Malaysai
Outcomes
Primary Outcome Measures
Measuring arterial stiffness (pulse wave velocity and augmentation index)
Secondary Outcome Measures
Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.
Full Information
NCT ID
NCT00489229
First Posted
June 20, 2007
Last Updated
July 15, 2009
Sponsor
Universiti Sains Malaysia
Collaborators
Ministry of Health, Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT00489229
Brief Title
To Investigate the Effect of Rosiglitazone and Ramipril on Pre-clinical Vasculopathy in Diabetes and IGT Patients
Official Title
Studies on Diabetic and Pre Diabetic Vascular Disease and the Effect of Selected Therapeutic Modalities on Associated Vasculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universiti Sains Malaysia
Collaborators
Ministry of Health, Malaysia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Impaired Glucose Tolerance
Keywords
Rosiglitazone, Ramipril, Impaired glucose tolerance, Arterial stiffness, Diabetic vasculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Type
Drug
Intervention Name(s)
Ramipril
Primary Outcome Measure Information:
Title
Measuring arterial stiffness (pulse wave velocity and augmentation index)
Time Frame
One year
Secondary Outcome Measure Information:
Title
Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Rashid A Rahman, MRCP, PhD
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Study Director
Facility Information:
Facility Name
School of Medical Sciences, University Sains Malaysai
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
22291490
Citation
Rahman S, Ismail AA, Ismail SB, Naing NN, Rahman AR. Effect of rosiglitazone and ramipril on macrovasculopathy in patients with type 2 diabetes: needs longer treatment and/or higher doses? Clin Pharmacol. 2010;2:83-7. doi: 10.2147/CPAA.S8863. Epub 2010 Apr 20.
Results Reference
derived
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To Investigate the Effect of Rosiglitazone and Ramipril on Pre-clinical Vasculopathy in Diabetes and IGT Patients
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