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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
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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Contacts

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

Locations

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

Principal Investigator:	Mustafa Kanat, MD	Abant Izzet Baysal University, Bolu Izzet Baysal School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00433823 History of Changes
Other Study ID Numbers:	MK-19
First Posted:	February 12, 2007
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:

Diabetes Mellitus; Heart Diseases; Hypercholesterolemia; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders	Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atorvastatin Calcium; Ezetimibe; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors