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A Study Evaluating the Effects of Lipid Lowering Treatment on Steroid Synthesis

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ClinicalTrials.gov Identifier: NCT00433823
Recruitment Status : Unknown
Verified February 2007 by Abant Izzet Baysal University.
Recruitment status was:  Recruiting
First Posted : February 12, 2007
Last Update Posted : February 12, 2007
Sponsor:
Information provided by:
Abant Izzet Baysal University

Study Description
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Brief Summary:
Cholesterol is the precursor of glucocorticoids, mineralocorticoids and sex steroids. Both adrenal and non-adrenal (ovarian + testicular) all steroid hormones are primarily synthesized using the LDL-cholesterol in the circulation. Additionally there is 'de novo' cholesterol synthesis in both the adrenals and gonads controlled by the HMG-CoA reductase enzyme. A third pathway is the use of circulatory HDL-cholesterol by the adrenal and gonadal tissues for the synthesis of steroids. Since statins both decrease circulatory LDL and inhibit de novo cholesterol synthesis, they are likely to affect the synthesis of steroid hormones. In this study we aim to investigate the effects of lowering LDL levels below 70 mg/dL on steroid hormone synthesis.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Diabetes Mellitus Non-Coronary Atherosclerotic Disease Hypercholesterolemia Drug: Atorvastatin, Ezetimibe Phase 4

Detailed Description:
Today atherosclerotic diseases are among the most important causes of death in the world. Epidemiological, clinical, genetic, experimental and pathological studies have clearly shown the role of lipoproteins in atherosclerosis. LDL is the major atherogenic lipoprotein and has been defined as the primary target of lipid lowering treatment by NCEP. Although the level of LDL, the primary target in the treatment of dyslipidemia, has been set as below 100mg/dl in coronary heart diseases (CHD) and CHD risk equivalents, this level has been pulled down to below 70mg/dl for the group defined as very high risk group by the ATP (Adult Treatment Panel) guide that has been updated following the new clinical studies. As we already know, cholesterol is the precursor of glucocorticoids, mineralocorticoids and sex steroids, besides being a structural component of the cell membrane. Both adrenal and non-adrenal (ovarian+testicular) all steroid hormones are primarily synthesized using the LDL-cholesterol in the circulation. In addition to this, there is 'de novo' cholesterol synthesis in both the adrenals and gonads controlled by the HMG-CoA reductase enzyme. A third pathway, which under normal circumstances has little contribution as compared to the first two, is the use of circulatory HDL-cholesterol by the adrenal and gonadal tissues for the synthesis of steroids. Our knowledge on extremely lowered LDL levels is quite limited. However, since statins both decrease circulatory LDL and inhibit de novo cholesterol synthesis, they are likely to affect the synthesis of steroid hormones.
Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Multicenter, Open Labeled, Cross-Over Designed Prospective Study Evaluating the Effects of Lipid Lowering Treatment on Steroid Synthesis
Study Start Date : January 2007
Study Completion Date : January 2008

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients in the very high risk group according to the ATPIII guide.

Exclusion Criteria:

  • Patients having a major disease involving hepatic, gastrointestinal and endocrinologic diseases other than diabetes.
  • Patients having a known muscle disease
  • Pregnancy, breast-feeding
  • Patients having a history of allergy to statins or ezetimibe
  • Nephropathic patients
Contacts and Locations
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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): NCT00433823


Contacts
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Contact: Mustafa Kanat, MD +905385448782 mustafa.kanat@gmail.com

Locations
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Turkey
Bolu Izzet Baysal School of Medicine Recruiting
Bolu, Turkey, 14280
Contact: Mustafa Kanat, MD    +905385448782    mustafa.kanat@gmail.com   
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
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Principal Investigator: Mustafa Kanat, MD Abant Izzet Baysal University, Bolu Izzet Baysal School of Medicine
More Information
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ClinicalTrials.gov Identifier: NCT00433823    
Other Study ID Numbers: MK-19
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: February 12, 2007
Last Verified: February 2007
Keywords provided by Abant Izzet Baysal University:
Very low level of LDL
Steroid hormones
Atorvastatin
Ezetimibe
Lipoprotein-a
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Hypercholesterolemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Atorvastatin
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors