The Genetics of Diabetes in Southern California Chinese Americans
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 15, 2009 | ||||||||
| Last Updated Date | February 2, 2011 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00824395 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Genetics of Diabetes in Southern California Chinese Americans | ||||||||
| Official Title ICMJE | Mitochondria and Metabolic Syndrome in a Southern California Chinese Cohort | ||||||||
| Brief Summary | The purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome. |
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| Detailed Description | Since our laboratory's initial linkage of Type 2 diabetes to a mtDNA rearrangement in a three generation maternal pedigree 13 years ago, there has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus (DM) and the overlapping Metabolic Syndrome (MS). With this study we are planning an extensive investigation of defects in mitochondrial oxidative phosphorylation (OXPHOS) caused potentially by deleterious sequence variants in the mitochondrial DNA (mtDNA). As the primary objective we are trying to further substantiate 2 hypotheses: 1) that these diabetogenic mtDNA variants, which are proposed to range from recent, relatively severe, mutations will result in substantial OXPHOS defects with familial DM & MS and 2) that ancient, relatively mild polymorphisms result in partial OXPHOS defects and an increase in the risk to develop DM & MS. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: whole blood and serum |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | We are currently recruiting Chinese Americans living in Southern California, espcially in Orange and Los Angeles Counties. We are particularly in need of Chinese American men and women with diabetes as well as healthy male controls. We can arrange for offsite weekend trips to cities within LA or Orange Counties for eligible groups of 10 or more people. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | November 2010 | ||||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00824395 | ||||||||
| Other Study ID Numbers ICMJE | 2005-4675 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Douglas C. Wallace, Ph.D / Principal Investigator, UC Irvine Center for Mitochondrial Medicine and Genetics | ||||||||
| Study Sponsor ICMJE | University of California, Irvine | ||||||||
| Collaborators ICMJE | Doris Duke Charitable Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||||||
| Verification Date | February 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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