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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Abant Izzet Baysal University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Abant Izzet Baysal University
ClinicalTrials.gov Identifier:
NCT00433823
First received: February 7, 2007
Last updated: February 9, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
Coronary Heart Disease
Diabetes Mellitus
Non-Coronary Atherosclerotic Disease
Hypercholesterolemia
Drug: Atorvastatin, Ezetimibe
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Multicenter, Open Labeled, Cross-Over Designed Prospective Study Evaluating the Effects of Lipid Lowering Treatment on Steroid Synthesis

Resource links provided by NLM:


Further study details as provided by Abant Izzet Baysal University:

Study Start Date: January 2007
Estimated Study Completion Date: January 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433823

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

No publications provided

ClinicalTrials.gov Identifier: NCT00433823     History of Changes
Other Study ID Numbers: MK-19
Study First Received: February 7, 2007
Last Updated: February 9, 2007
Health Authority: Turkey: Ministry of Health

Keywords provided by Abant Izzet Baysal University:
Very low level of LDL
Steroid hormones
Atorvastatin
Ezetimibe
Lipoprotein-a

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Heart Diseases
Hypercholesterolemia
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Atorvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014