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NCT00094796 · ClinicalTrials.gov registry record · Phase 2
Rosiglitazone to Reverse Metabolic Defects in Diabetes
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT00094796 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 70 participants.
The verdict
NCT00094796, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study 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-diabetes. The underlying problem in people with diabetes or pre-diabetes is insulin resistance (lowered sensitivity to insulin) resulting in poor glucose (sugar) regulation. Rosiglitazone improves the body's sensitivity to insulin. Patients 21 years of age and older who have type 2 diabetes or who are pre-diabetic (glucose intolerant/insulin resistant) may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, echocardiography (heart ultrasound), exercise test, brachial artery reactivity test (see below), and possibly a muscle biopsy. Participants take one rosiglitazone tablet daily by mouth for 2 weeks. The dose is then increased to two tablets daily for another 2 weeks and then to 4 tablets daily for the remainder of the 12-week treatment period. In addition to treatment, patients undergo the following tests and procedures: * Resting and exercise metabolic testing: The amount of oxygen taken in and carbon dioxide exhaled during breathing is measured while the patient rests in a chair and then while he or she exercises on a stationary bicycle or treadmill. Both at rest and during exercise, the patient wears a facemask that measures the amount of oxygen used. During exercise, heart rate is monitored with electrodes on the chest, arms, and thighs. The exercise test is repeated three times, once to become familiar with the test, again the next day to measure exercise capacity, and again 3 days later. The third test is less strenuous and is optional. * Muscle biopsy (optional): A small area of skin over a calf muscle is numbed with a local anesthetic and a 1-inch incision is made over the muscle. A small amount of muscle tissue is taken and the incision is closed with stitches. * Brachial reactivity study: This ultraso
Interventions
- PROCEDURE Exercise cardiopulmonary metabolic testing
- PROCEDURE Skeletal muscle biopsy
- PROCEDURE Brachial artery reactivity testing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2004-10-20 |
| Est. Completion | 2008-09-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094796
The ClinicalTrials.gov registry entry for NCT00094796 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Exercise cardiopulmonary metabolic testing is the first listed.
NCT00094796 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00094796 about?
NCT00094796 is a clinical study titled "Rosiglitazone to Reverse Metabolic Defects in Diabetes". 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-diabetes. The underlying problem in people with diabetes or pre-diabetes is insulin resistance (lowered ...
What is the current status of trial NCT00094796?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2004-10-20. Estimated completion is 2008-09-03.
What interventions are being tested in trial NCT00094796?
The interventions under investigation include: Exercise cardiopulmonary metabolic testing (PROCEDURE), Skeletal muscle biopsy (PROCEDURE), Brachial artery reactivity testing (PROCEDURE).
Who is sponsoring clinical trial NCT00094796?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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