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Effect of Diabetes Mellitus on Cholesterol Metabolism

This study is currently recruiting participants.
Verified October 2012 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Srividya Kidambi, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00879710
First received: April 8, 2009
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Hypercholesterolemia
 Drug: simvastatin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Diabetes Mellitus on Cholesterol Absorption, Synthesis and Statin Efficacy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Lowering of LDL cholesterol [ Time Frame: 6 weeks after starting drug therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in cholesterol absorption or synthesis rates from the baseline [ Time Frame: 6 weeks after initiation of drug therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: August 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Subjects with type 1 diabetes mellitus,
  • Simvastatin 40 mg tablet by month daily for 6 weeks,
  • 4 weeks washout period
  • Ezetimibe 10 mg by month for 6 weeks
 Drug: simvastatin
Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist.
Other Name: Zocor or zetia
Subjects with type 2 diabetes mellitus
  • Simvastatin 40 mg tablet by month daily for 6 weeks,
  • 4 weeks washout period
  • Ezetimibe 10 mg by month for 6 weeks
 Drug: simvastatin
Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist.
Other Name: Zocor or zetia

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 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 Criteria:

  • 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®
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879710

Contacts
Contact: Gerard Coly, MD 414-456-7438 gcoly@mcw.edu

Locations
United States, Wisconsin
Medical College of Wisconsin /Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Gerard Coly, Md     414-456-7438     gcoly@mcw.edu    
Contact: Srividya Kidambi, MD     414-955-6724     skidambi@mcw.edu    
Principal Investigator: Shailendra B Patel, MD, PhD            
Sub-Investigator: Srividya Kidambi, MD            
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Shailendra B Patel, MD, PhD Medical College of Wisconsin
Principal Investigator: Srividya Kidambi, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Srividya Kidambi, MD, Assistant Professor, Endocrinology, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00879710     History of Changes
Other Study ID Numbers: PRO00002485
Study First Received: April 8, 2009
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
Diabetes Mellitus
Hypercholesterolemia
Simvastatin
Ezetimibe.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Simvastatin
Ezetimibe
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013