Status:
COMPLETED
Rosiglitazone to Reverse Metabolic Defects in Diabetes
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Diabetes Mellitus, Type II
Insulin Resistance
Eligibility:
All Genders
22+ years
Phase:
PHASE2
Brief Summary
This study will examine whether the anti-diabetes medicine rosiglitazone can safely and effectively reverse the early problems of type 2 diabetes and delay the onset of disease in people with pre-diab...
Detailed Description
The majority of insulin resistant individuals (predominantly individuals with type 2 diabetes - T2DM) develop a disproportionate incidence of cardiovascular disease burden including hypertension, coro...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Adults older than 21 years.
- Subjects must either have:
- Insulin resistance as defined by a fasting blood sugar of greater than 110mg/dl and less than 126 mg/dl and confirmed with the QUICKI test.
- or the diagnosis of T2DM with a HBA1c less than 9%, a fasting insulin level of greater than 6 UIU/ml and a fasting blood glucose level of greater than 125 mg/dl if not on anti-diabetic therapy.
- Subject understands protocol and provides written, informed consent
- Patients must demonstrate the capacity for a near maximal to maximal effort on a treadmill as measured by exercise ventilatory threshold. This will be measured by achieving a peak respiratory exchange ratio greater than or equal to 1.00 during the initial and final peak VO2 exercise tests.
- EXCLUSION CRITERIA:
- Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography or unstable coronary disease within the last 3 months.
- Uncontrolled hypertension.
- History of Heart Failure.
- Left ventricular ejection fraction less than 55% as measured by screening echocardiogram.
- Subject physically unable to perform treadmill exercise due to neurologic or orthopedic conditions.
- Insulin-dependent diabetes mellitus or current use of thiazolidinediones
- History of adverse events on thiazolidinedione therapy
- Women of childbearing age unless recent pregnancy test is negative.
- Lactating women.
- Serum creatinine greater than 2.5 mg/dl
- Liver transaminase levels greater than 2.5 x upper limit of normal
- History of cancer in the last 5 years
- History of treatment for any illness with stem cell transplantation
- Active inflammatory disease
- Enrollment in a any drug studies within the last 30 days
Exclusion
Key Trial Info
Start Date :
October 20 2004
Trial Type :
INTERVENTIONAL
End Date :
September 3 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00094796
Start Date
October 20 2004
End Date
September 3 2008
Last Update
July 2 2017
Active Locations (2)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
2
Medical College of Virginia
Richmond, Virginia, United States