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Effects of Rosuvastatin on the, in Vivo, Kinetic of apoB and apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00658463
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : April 15, 2008
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Centre Hospitalier Universitaire Dijon

Brief Summary:

Statins have been shown to reduce significantly the risk for cardiovascular events in patients with type 2 diabetes and statin therapy is largely recommended in this high cardiovascular risk population. However, a residual cardiovascular risk is observed in patients with type 2 diabetes treated by statins. This may be due to the fact that statins do not correct all lipid abnormalities associated with diabetic dyslipidaemia, such as hyperTG and low HDL-cholesterol.

Rosuvastatin is a statin which, in addition to its efficacy to reduce LDL-cholesterol, has been show to decrease significantly plasma triglycerides. However, the effects of rosuvastatin on triglyceride rich lipoproteins and HDL remains unknown. The purpose of this study is to analyze the effect rosuvastatin 20 mg on the metabolism of triglyceride rich lipoproteins and HDL in patients with Type 2 diabetes using and in vivo kinetic study of VLDL1-apoB,VLDL2-apoB,IDL-apoB and HDL-apoA1.


Condition or disease Intervention/treatment Phase
Diabetes Drug: Rosuvastatin Drug: Placebo Phase 4

Detailed Description:

This is a randomized, double blinded, placebo-controlled, monocentric, cross-over study with two 6-week periods of placebo or rosuvastatin. Subjects will enter a one month placebo lead-in period after which they will be eligible for rosuvastatin 20 mg or placebo for two 6-week periods.

An in vivo kinetic study will be performed with stable isotopes (13C leucine) in type 2 diabetic patients (n=8) before and after a 6-week period of rosuvastatin (20mg) therapy. The study is design with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg. An in vivo kinetic study will be performed at the end of each 6-week period.

The kinetic studies performed, in each patient, will assess the production rates and fractional rates of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Rosuvastatin on the, in Vivo, Kinetic of VLDL apoB, IDL apoB, LDL apoB and HDL apoA1, Using Stable Isotopes, in Type 2 Diabetic Patients
Study Start Date : January 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
The study is designed with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg). An in vivo kinetic study will be performed at the end of each 6-week period.
Drug: Rosuvastatin
rosuvastatin 20 mg/day during 6 weeks versus placebo during 6 weeks in a cross-over design
Other Name: CRESTOR (brand name for rosuvastatin)

Placebo Comparator: 2
The study is designed with a one-month steady state period with placebo then on a cross-over design with two 6-week periods of placebo or rosuvastatin (20 mg). An in vivo kinetic study will be performed at the end of each 6-week period.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Fractional Catabolic Rates (FCR)of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I [ Time Frame: At the end of each treatment period (rosuvastatin or placebo) ]

Secondary Outcome Measures :
  1. Production Rates (PR) of VLDL1-apoB, VLDL2-apoB, IDL-apoB, LDL-apoB and HDL-apoA-I [ Time Frame: At the end of each treatment period (rosuvastatin or placebo) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Type 2 diabetic patients (age: 30 to 75 years) treated by one or two oral agents at fixed dose (sulfonylureas, metformin, alpha glucosidase inhibitors) for at least 6 months
  • Fasting triglycerides >= 150 mg/dl
  • HDL-C < 40 mg/dl in men and < 50 mg/dl in women (NCEP ATPIII lipid criteria for the metabolic syndrome)
  • Patients not receiving hypolipidemic agents since at least 6 months
  • Diabetic patients with stable HbA1c during the last 6 months
  • Subjects willing to follow all study procedures including attendance at clinic for scheduled study visits and compliance with study treatment regimen

Exclusion Criteria:

  • HbA1c > 9 %
  • LDL-C > 190 mg/dl
  • Known heterozygous or homozygous familial hypercholesterolaemia or known type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia
  • Documented secondary hypercholesterolaemia of any cause
  • History of serious adverse effect or hypersensitivity reactions to other HMG-CoA reductase inhibitors, in particular any history of myopathy
  • Pregnant women, women who are breast feeding and women of childbearing potential who are not using chemical or mechanical contraception (prescription oral contraceptives, abstinence, condoms with spermicide, surgical sterilisation, diaphragm with spermicide or intrauterine device) or have positive pregnancy test
  • History of malignancy, except subjects who have been disease free for more than 10 years or whose only malignancy has been basal or squamous cell skin carcinoma. Women with a history of cervical dysplasia should be excluded unless 3 consecutive normal cervical smears have subsequently been recorded before entry into the study
  • History of alcohol and/or drug abuse
  • Active liver disease or hepatic dysfunction as defined by elevations of AST or ALT * 2 times the ULN. In this case, a second determination of hepatic tests will be performed after one week. If the dysfunction is confirmed, the subject must not be included in the study
  • Patient with acromegaly or Cushing syndrome
  • Patient receiving insulin treatment
  • Use of drugs known to affect lipid metabolism: corticoids, retinoids, antiproteases, estrogens, cyclosporin, glitazones, statins other than rosuvastatin, fibrates, cholestyramine, nicotinic acid, omega 3 or phytosterols
  • Renal impairment as defined by creatinine clearance < 30 ml/min.
  • Unstable angina or manifestation of severe atherosclerosis.
  • Uncontrolled hypertension defined as either resting diastolic blood pressure of >95mmHg or resting systolic blood pressure of >200 mmHg.
  • Unexplained serum CK > 3 times ULN (eg. not due to recent trauma, intramuscular injections, heavy exercise, etc).
  • Participation in another investigational drug trial within 4 weeks prior to randomization.
  • Subjects with serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the trial.
  • Subjects with serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658463


Locations
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France
Centre Hospitalier Universitaire de Dijon
Dijon, France, 21000
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
AstraZeneca
Investigators
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Principal Investigator: Bruno Vergès, MD Centre Hospitalier Universitaire Dijon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Bruno Vergès, Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT00658463    
Other Study ID Numbers: AFSSAPS 041348
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: April 15, 2008
Last Verified: March 2008
Keywords provided by Centre Hospitalier Universitaire Dijon:
Diabetes
Triglycerides
HDL-cholesterol
kinetic
rosuvastatin
Additional relevant MeSH terms:
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Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors