N/A
N=57
Effect of Diabetes Mellitus on Cholesterol Metabolism
Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus · Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00879710 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Changes in LDL Cholesterol — -0.83; -1.47; -0.93; -0.32 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- simvastatin or ezetimibe (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in LDL Cholesterol |
-0.83; -1.47; -0.93; -0.32 | — |
| SECONDARY Changes in Cholesterol Absorption or Synthesis Rates From the Baseline |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 18 years
- Subjects diagnosed with type II DM (diagnosed as adult onset, not-insulin dependent and not on insulin)
- Stable A1C 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 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®
Data sourced from ClinicalTrials.gov (NCT00879710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.