The Roles of SAH Gene Family in Athrogenic Dyslipidemia in Postmenopausal Women (MOSAH-S2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT00945217
First received: April 17, 2009
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

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). The National Cholesterol Education Program (NCEP) recommended using non-high-density lipoprotein cholesterol (non-HDL-C) to surrogate atherogenic lipoproteins in clinical practice. Recently, the investigators have done a pilot study to study the associations between SAH gene variants and atherogenic dyslipidemia (surrogated by non-HDL-C) in postmenopausal women. The investigators 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. Based on the findings of the pilot study, the investigators 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. 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.


Condition
Disorder Associated With Menstruation and/or Menopause
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Genetic Probes of Atherogenic Dyslipidemia: The Roles of the SAH Gene Family (Study 2. Postmenopausal Women)

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Samples With DNA - samples retained, with potential for extraction of DNA from buffy coats


Estimated Enrollment: 660
Study Start Date: October 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Postmenopausal women
women with natural menopause

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Volunteers with natural menopause from a research clinic

Criteria

Inclusion Criteria:

  • Naturally postmenopausal women
  • Not menstruated within the last 12 months.
  • Willing to participate by signing an informed consent

Exclusion Criteria:

  • Patients of known history of type 2 diabetes.
  • Those with fasting glucose ≥ 126 mg/dL.
  • History of major renal, liver, heart, and neurological disease.
  • History of hyperthyroidism or hypothyroidism.
  • History of acute illness in the past 6 months.
  • History of alcoholism or drug abuse.
  • Women who are pregnant.
  • Current or concomitant illness that would interfere with the subject's ability to perform the study or that would confound the study results, judged by the investigation physicians.
  • Any concomitant medication within 2 weeks of the study.
  • Difficult venous access
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945217

Contacts
Contact: Chii-Min Hwu, MD 886228757516 chhwu@vghtpe.gov.tw

Locations
Taiwan
Section of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Chii-Min Hwu, MD    88622875716    chhwu@vghtpe.gov.tw   
Principal Investigator: Chii-Min Hwu, MD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: Chii-Min Hwu, MD Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: vghtpe user, Attending Physician, Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier: NCT00945217     History of Changes
Other Study ID Numbers: 98-01-63A
Study First Received: April 17, 2009
Last Updated: December 5, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Atherogenic dyslipidemia
Non-HDL-C
Postmenopausal women
SAH gene family

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 31, 2014