NCT00489229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2007

Completed
Last Updated

July 16, 2009

Status Verified

March 1, 2007

First QC Date

June 20, 2007

Last Update Submit

July 15, 2009

Conditions

DiabetesImpaired Glucose Tolerance

Keywords

RosiglitazoneRamiprilImpaired glucose toleranceArterial stiffnessDiabetic vasculopathy

Outcome Measures

Primary Outcomes (1)

  • Measuring arterial stiffness (pulse wave velocity and augmentation index)

    One year

Secondary Outcomes (1)

  • Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.

    One year

Interventions

RosiglitazoneDRUG
RamiprilDRUG

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Medical Sciences, University Sains Malaysai

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (1)

  • 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.

    PMID: 22291490DERIVED

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Interventions

RosiglitazoneRamipril

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Abdul Rashid A Rahman, MRCP, PhD

    Universiti Sains Malaysia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2007

First Posted

June 21, 2007

Study Start

October 1, 2002

Study Completion

December 1, 2005

Last Updated

July 16, 2009

Record last verified: 2007-03

Locations

MY(1)