|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00489229 |
|
Date of registration:
|
20/06/2007 |
|
Primary sponsor: |
|
|
Public title:
|
To Investigate the Effect of Rosiglitazone and Ramipril on Pre-clinical Vasculopathy in Diabetes and IGT Patients
|
|
Scientific title:
|
Studies on Diabetic and Pre Diabetic Vascular Disease and the Effect of Selected Therapeutic Modalities on Associated Vasculopathy |
|
Date of first enrolment:
|
October 2002 |
|
Target sample size:
|
66 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00489229 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Malaysia
| | | | | | | |
|
Contacts
|
|
Name:
|
Abdul Rashid A Rahman, MRCP, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Science Malaysia |
| | |
|
Key inclusion & exclusion 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)
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes
|
|
Impaired Glucose Tolerance
|
|
Intervention(s)
|
|
Drug: Ramipril
|
|
Drug: Rosiglitazone
|
|
Primary Outcome(s)
|
|
Measuring arterial stiffness (pulse wave velocity and augmentation index)
[Time Frame: One year]
|
|
Secondary Outcome(s)
|
|
Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.
[Time Frame: One year]
|
|
Secondary ID(s)
|
|
ID: 305/PPSP/6112215
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|