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NCT00879710 · ClinicalTrials.gov registry record · NA
Effect of Diabetes Mellitus on Cholesterol Metabolism
A NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT00879710: Completed NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, sponsored by Medical College of Wisconsin.
NCT00879710 is a NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus that has completed, run by Medical College of Wisconsin. The registered enrollment target is 57 participants, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879710, a NA study of Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
HMG CoA reductase inhibitors (statins) are commonly used to treat high cholesterol (HC) in both type 1 and type 2 diabetes mellitus (DM). Several studies have shown benefits of statin among patients of type 2 DM, however, no such data is available for patients with type 1 DM. It is known from studies on cholesterol metabolism using surrogate markers that patients with type 1 DM have higher cholesterol absorption compared to normals and those with type 2 DM have higher cholesterol synthesis. Since statins inhibit synthesis, patients with type 1 DM may not have a good response and may respond better to cholesterol absorption inhibitors. The purpose of this study is to determine the cholesterol lowering effects of cholesterol absorption inhibitors and cholesterol synthesis inhibitors in subjects with type 1 and type 2 diabetes mellitus.
Primary Outcome
Subjects with T1DM or T2DM were assigned to alternating therapy with simvastatin (40 mg) or ezetimibe (10 mg) for 6 weeks in a crossover design. The data are reported as follows. Subjects with type 1 diabetes mellitus: Simvastatin: Changes in LDL after 6-week therapy with simvastatin (irrespective of the treatment order) Ezetimibe: Changes in LDL after 6-week therapy with ezetimibe (irrespective of the treatment order) Subjects with type 2 diabetes mellitus: Simvastatin: Changes in LDL afte
Conditions Studied
Interventions
- DRUG simvastatin or ezetimibe
Study Locations (1)
Wisconsin
- Medical College of Wisconsin /Froedtert Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2008-08 |
| Est. Completion | 2013-07 |
| Phase | NA |
What the finished NCT00879710 record still lists
NCT00879710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 2,959-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which simvastatin or ezetimibe is the first listed.
NCT00879710 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00879710 about?
NCT00879710 is a clinical study titled "Effect of Diabetes Mellitus on Cholesterol Metabolism". HMG CoA reductase inhibitors (statins) are commonly used to treat high cholesterol (HC) in both type 1 and type 2 diabetes mellitus (DM). Several studies have shown benefits of statin among patients of type 2 DM, however, no such data is available for patients with type 1 DM. It is known from studi...
What is the current status of trial NCT00879710?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2008-08. Estimated completion is 2013-07.
What conditions does trial NCT00879710 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, Hypercholesterolemia.
What interventions are being tested in trial NCT00879710?
The interventions under investigation include: simvastatin or ezetimibe (DRUG).
Who is sponsoring clinical trial NCT00879710?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00879710 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00879710's enrollment target sits among peer trials
57 76th of 130 higher than 54 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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