DiabetesPhase 3NCT00489229
To Investigate the Effect of Rosiglitazone and Ramipril on Pre-clinical Vasculopathy in Diabetes and IGT Patients
A Phase 3 study testing Rosiglitazone and Ramipril in people with Diabetes and Impaired Glucose Tolerance, run by Universiti Sains Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetes, Impaired Glucose Tolerance
- What is being tested?
- Rosiglitazone and Ramipril
- How many people
- 66 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2002to Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed untreated T2DM patients
- Newly diagnosed untreated IGT patients
- Normoglycaemic individuals
- Age: 30-65 years
- Blood Pressure <140/90 mmHg.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
School of Medical Sciences, University Sains Malaysai
Kota Bharu, Kelantan, 16150
About this study
Official title: Studies on Diabetic and Pre Diabetic Vascular Disease and the Effect of Selected Therapeutic Modalities on Associated Vasculopathy
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.
Read the 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.
- Conditions
- Diabetes, Impaired Glucose Tolerance
- Being tested
- Rosiglitazone, Ramipril
- Keywords
- Rosiglitazone, Ramipril, Impaired glucose tolerance, Arterial stiffness, Diabetic vasculopathy
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosiglitazoneDrug
RamiprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring arterial stiffness (pulse wave velocity and augmentation index)
Measured: One year
Secondary outcomes (1)
Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startOct 2002
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Investigators
- Abdul Rashid A Rahman, MRCP, PhD, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489229
- Sponsor's protocol ID
- ID: 305/PPSP/6112215
- Status last verified
- Mar 2007
- First submitted
- 20 Jun 2007
- Last updated
- 16 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22291490
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies on Diabetic and Pre Diabetic Vascular Disease and the Effect of Selected Therapeutic Modalities on Associated Vasculopathy
- ClinicalTrials.gov ID
- NCT00489229
- Acronym / sponsor ID
- ID: 305/PPSP/6112215
- Conditions
- Diabetes, Impaired Glucose Tolerance
- Keywords
- Rosiglitazone, Ramipril, Impaired glucose tolerance, Arterial stiffness, Diabetic vasculopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- Oct 2002
- Study completion
- Dec 2005 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed untreated T2DM patients
- Newly diagnosed untreated IGT patients
- Normoglycaemic individuals
- Age: 30-65 years
- Blood Pressure <140/90 mmHg.
Key exclusion criteria (6 listed)
- Patients with T2DM
- Hypertension (>140/90 mmHg)
- Microvascular and/or macrovascular complications of diabetes
- Severe hyperlipidaemia (>7.8 mmol/L)
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosiglitazone | Drug | – |
| Ramipril | Drug | – |
Primary outcome
Measuring arterial stiffness (pulse wave velocity and augmentation index)
Time frame: One year
1 secondary outcome
Measuring fasting blood sugar and 2 hours post prandial sugars, fasting insulin level, HbA1c, and total cholesterol level.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2009.
- Derived from this study: PubMed 22291490Rahman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Rashid A Rahman, MRCP, PhD study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rosiglitazone and Ramipril in people with Diabetes and Impaired Glucose Tolerance, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring arterial stiffness (pulse wave velocity and augmentation index) (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00489229, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2009.