Viewing Study NCT00433823



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Study NCT ID: NCT00433823
Status: UNKNOWN
Last Update Posted: 2007-02-12
First Post: 2007-02-07

Brief Title: A Study Evaluating the Effects of Lipid Lowering Treatment on Steroid Synthesis
Sponsor: Abant Izzet Baysal University
Organization: Abant Izzet Baysal University

Study Overview

Official Title: A Multicenter Open Labeled Cross-Over Designed Prospective Study Evaluating the Effects of Lipid Lowering Treatment on Steroid Synthesis
Status: UNKNOWN
Status Verified Date: 2007-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 mgdL on steroid hormone synthesis
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 100mgdl in coronary heart diseases CHD and CHD risk equivalents this level has been pulled down to below 70mgdl 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 ovariantesticular 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None