The Roles of SAH Gene Family in Athrogenic Dyslipidemia in Postmenopausal Women (MOSAH-S2)
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|ClinicalTrials.gov Identifier: NCT00945217|
Recruitment Status : Unknown
Verified December 2011 by vghtpe user, Taipei Veterans General Hospital, Taiwan.
Recruitment status was: Recruiting
First Posted : July 24, 2009
Last Update Posted : December 6, 2011
|Condition or disease|
|Disorder Associated With Menstruation and/or Menopause Dyslipidemia|
Atherogenic dyslipidemia is characterized by high levels of apolipoprotein B (apoB)-containing lipoproteins, including very-low-density lipoprotein (VLDL) and its remnants and small, dense LDL (sdLDL) particles, and reduced levels of high-density lipoprotein cholesterol (HDL-C). Extensive evidence shows that atherogenic dyslipidemia contributes not only to residual macrovascular risk but also to inflammation and microvascular complications. The National Cholesterol Education Program (NCEP) recommended using non-high-density lipoprotein cholesterol (non-HDL-C) to surrogate atherogenic lipoproteins in clinical practice. Elevated non-HDL-C may represent abnormal secretion, abnormal catabolism, and/or abnormal hepatic uptake of triglycerides (TG)-rich lipoproteins. Recently, we have done a pilot study to study the associations between SAH gene variants and atherogenic dyslipidemia (surrogated by non-HDL-C) in postmenopausal women. We found that homozygosity for SAH haplotype 3 was associated with increased adiposity, insulin resistance, and elevated levels of non-HDL-C in the postmenopausal women. Moreover, researchers have identified that there are at least four members in the SAH gene family: SAH, MACS1, MACS2, and MACS3. All of them seem to have acyl-CoA synthetase activity toward medium-chain fatty acids and all are clustered in chromosome 16p12. In the present study, we propose to do a two-year study to examine the associations between the SAH gene family and atherogenic dyslipidemia in postmenopausal women.
Based on the findings of the pilot study, we plan to expand the cohort of postmenopausal women to about 800 women, that is, recruited 660 new subjects in two years. The associations between non-HDL-C and the SAH gene family will be done 18 months after the study started. Fasting blood sampling for buffy coats and lipids is the core test of Study 2. A 75-g oral glucose tolerance test (OGTT) will be available as an optional test for a better phenotyping of insulin resistance for the participants. Detailed lipid profiling including measurements of VLDL cholesterol, VLDL-TG, remnant lipoprotein, LDL particle size, apoA1, apoB, and apoCIII will be done in the second year of the study if significant associations between gene variants of the SAH gene family and non-HDL-C are detected.
|Study Type :||Observational|
|Estimated Enrollment :||660 participants|
|Official Title:||Genetic Probes of Atherogenic Dyslipidemia: The Roles of the SAH Gene Family (Study 2. Postmenopausal Women)|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||July 2012|
women with natural menopause
- the differences in haplotype frequencies of the SAH gene between two groups of subjects with different levels of non-HDL-C. [ Time Frame: 2 years ]
- the differences in haplotype frequencies of other members of the SAH gene family between two groups of subjects with different levels of non-HDL-C. [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945217
|Contact: Chii-Min Hwu, MDemail@example.com|
|Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital||Recruiting|
|Taipei, Taiwan, 112|
|Contact: Chii-Min Hwu, MD 88622875716 firstname.lastname@example.org|
|Principal Investigator: Chii-Min Hwu, MD|
|Principal Investigator:||Chii-Min Hwu, MD||Taipei Veterans General Hospital, Taiwan|