Status:
COMPLETED
Effect of Diabetes Mellitus on Cholesterol Metabolism
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
Detailed Description
Hypothesis: 1. Cholesterol absorption inhibitors like ezetimibe are more effective in lowering cholesterol in subjects with type 1 diabetes mellitus . The primary outcome measures are LDL cholesterol...
Eligibility Criteria
Inclusion
- Type 1 DM:
- Age \> 18 years
- Subjects diagnosed with type 1 DM (diagnosed based upon history of ketoacidosis, proven insulin dependence, absent C-peptide and or positive autoantibody profile (such as anti-GAD etc.)
- Stable A1C \< 8.5%
- BMI \< 31
- Type 2 DM:
- Age \> 18 years
- Subjects diagnosed with type II DM (diagnosed as adult onset, not-insulin dependent and not on insulin)
- Stable A1C \< 8.5%
- BMI \< 31
Exclusion
- History of active, unstable cardiovascular disease (including MI, CHF, Stroke, Angina, CABG, stenting/PTCA, peripheral vascular disease, intermittent claudication)
- Pregnancy, nursing or likely to get pregnant during the course of the study (not on oral contraceptives and premenopausal)
- Chronic Kidney Disease (creatinine \> 2.0)
- Liver function test abnormalities, not previously worked up (AST or ALT \>4x upper limit of normal)
- Active substance abuse including alcohol
- History of severe Hypertriglyceridemia (untreated TG \> 500) and on therapy
- Use of agents that interfere with cholesterol absorption (such as fiber, resins etc.) which can not be discontinued for the duration of the study
- Actively enrolled in a weight loss program or following a special diet ( e.g.: Atkins diet)
- History of malignancy \<5y
- History of Rhabdomyolysis and Myopathy
- Use of on-going oral corticosteroids
- History of HIV infection
- Use of following drugs/compounds: cyclosporine, itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, niacin, amiodarone, verapamil or large quantities of grape fruit juice (\> 1 quart per day)
- Proteinuria: more than or equal to 300mg/24 hours calculated from random urine specimen.
- BMI \>31
- Anyone with hypersensitivity to either one of the study medications
- Allergy to Soy bean products
- Unable to consume milk products with or without Lactaid®
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00879710
Start Date
August 1 2008
End Date
July 1 2013
Last Update
July 29 2020
Active Locations (1)
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1
Medical College of Wisconsin /Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226