Central Obesity and Disease Risk in Japanese Americans
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Atherosclerosis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005365
First Posted
May 25, 2000
Last Updated
February 8, 2016
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005365
Brief Title
Central Obesity and Disease Risk in Japanese Americans
Study Type
Observational
2. Study Status
Record Verification Date
August 2004
Overall Recruitment Status
Completed
Study Start Date
February 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To conduct a longitudinal study of central obesity and related risk factors found to be associated with hypertension and atherosclerotic cardiovascular disease (ASCVD) in a previously-examined cross-sectional cohort of second-generation Japanese Americans and in a newly-recruited cohort of third generation Japanese Americans.
Detailed Description
BACKGROUND:
The study was conducted in response to a program announcment issued in 1991 on obesity and tests the hypothesis that atherosclerotic cardiovascular disease (ASCVD), hypertension, and/or non-insulin dependent diabetes mellitus (NIDDM) develop in Japanese Americans when there is a truncal pattern of weight gain (central adiposity), which is in turn accompanied by insulin resistance, hyperinsulinemia, and lipid abnormalities. This cluster of abnormalities has been called 'Syndrome X'. It is postulated that 'Syndrome X' develops in Japanese Americans in response to environmental (behavioral) factors, many of which reflect 'westernization' in this ethnic group. The research plan focuses upon the relationship between central obesity and metabolic changes and disease outcomes associated with 'Syndrome X' along with the behavioral variables that potential risk factors for the development of this cluster of abnormalities.
DESIGN NARRATIVE:
The cohort was re-examined for diabetes, hypertension, coronary heart, disease, peripheral vascular disease, and a number of potential coronary heart disease risk factors including medical history, health practice, social history, diet, glycosylated hemoglobin, insulin, proinsulin, c-peptide, glucose, anthrometric measurements, lipids, and computed tomography on the thorax, abdomen, and thigh.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Atherosclerosis, Hypertension, Obesity, Diabetes Mellitus, Non-insulin Dependent, Hyperinsulinism, Insulin Resistance, Coronary Arteriosclerosis, Diabetes Mellitus, Metabolic Syndrome X
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfred Fujimoto
Organizational Affiliation
University of Washington
12. IPD Sharing Statement
Citations:
PubMed Identifier
9024255
Citation
Weigle DS, Ganter SL, Kuijper JL, Leonetti DL, Boyko EJ, Fujimoto WY. Effect of regional fat distribution and Prader-Willi syndrome on plasma leptin levels. J Clin Endocrinol Metab. 1997 Feb;82(2):566-70. doi: 10.1210/jcem.82.2.3761.
Results Reference
background
PubMed Identifier
8982018
Citation
Boyko EJ, Leonetti DL, Bergstrom RW, Fujimoto WY. Fasting insulin level underestimates risk of non-insulin-dependent diabetes mellitus due to confounding by insulin secretion. Am J Epidemiol. 1997 Jan 1;145(1):18-23. doi: 10.1093/oxfordjournals.aje.a009027.
Results Reference
background
PubMed Identifier
8880345
Citation
Boyko EJ, Leonetti DL, Bergstrom RW, Newell-Morris L, Fujimoto WY. Visceral adiposity, fasting plasma insulin, and lipid and lipoprotein levels in Japanese Americans. Int J Obes Relat Metab Disord. 1996 Sep;20(9):801-8.
Results Reference
background
PubMed Identifier
8898777
Citation
Fujimoto W, Boyko EJ, Leonetti DL, Bergstrom R, Newell-Morris L, Wahl PW. Hypertension in Japanese Americans: the Seattle Japanese-American Community Diabetes Study. Public Health Rep. 1996;111 Suppl 2(Suppl 2):56-8.
Results Reference
background
PubMed Identifier
8690145
Citation
Boyko EJ, Leonetti DL, Bergstrom RW, Newell-Morris L, Fujimoto WY. Low insulin secretion and high fasting insulin and C-peptide levels predict increased visceral adiposity. 5-year follow-up among initially nondiabetic Japanese-American men. Diabetes. 1996 Aug;45(8):1010-5. doi: 10.2337/diab.45.8.1010.
Results Reference
background
PubMed Identifier
8581774
Citation
Fujimoto WY, Bergstrom RW, Boyko EJ, Leonetti DL, Newell-Morris LL, Wahl PW. Susceptibility to development of central adiposity among populations. Obes Res. 1995 Sep;3 Suppl 2:179S-186S. doi: 10.1002/j.1550-8528.1995.tb00461.x.
Results Reference
background
PubMed Identifier
7555498
Citation
Chen KW, Boyko EJ, Bergstrom RW, Leonetti DL, Newell-Morris L, Wahl PW, Fujimoto WY. Earlier appearance of impaired insulin secretion than of visceral adiposity in the pathogenesis of NIDDM. 5-Year follow-up of initially nondiabetic Japanese-American men. Diabetes Care. 1995 Jun;18(6):747-53. doi: 10.2337/diacare.18.6.747.
Results Reference
background
PubMed Identifier
7729294
Citation
Boyko EJ, Leonetti DL, Bergstrom RW, Newell-Morris L, Fujimoto WY. Visceral adiposity, fasting plasma insulin, and blood pressure in Japanese-Americans. Diabetes Care. 1995 Feb;18(2):174-81. doi: 10.2337/diacare.18.2.174.
Results Reference
background
PubMed Identifier
7859632
Citation
Fujimoto WY, Bergstrom RW, Boyko EJ, Kinyoun JL, Leonetti DL, Newell-Morris LL, Robinson LR, Shuman WP, Stolov WC, Tsunehara CH, et al. Diabetes and diabetes risk factors in second- and third-generation Japanese Americans in Seattle, Washington. Diabetes Res Clin Pract. 1994 Oct;24 Suppl:S43-52. doi: 10.1016/0168-8227(94)90226-7.
Results Reference
background
PubMed Identifier
10805506
Citation
Tsai EC, Boyko EJ, Leonetti DL, Fujimoto WY. Low serum testosterone level as a predictor of increased visceral fat in Japanese-American men. Int J Obes Relat Metab Disord. 2000 Apr;24(4):485-91. doi: 10.1038/sj.ijo.0801183.
Results Reference
background
PubMed Identifier
10546012
Citation
Fujimoto WY, Bergstrom RW, Boyko EJ, Chen KW, Leonetti DL, Newell-Morris L, Shofer JB, Wahl PW. Visceral adiposity and incident coronary heart disease in Japanese-American men. The 10-year follow-up results of the Seattle Japanese-American Community Diabetes Study. Diabetes Care. 1999 Nov;22(11):1808-12. doi: 10.2337/diacare.22.11.1808.
Results Reference
background
PubMed Identifier
10333905
Citation
McNeely MJ, Boyko EJ, Weigle DS, Shofer JB, Chessler SD, Leonnetti DL, Fujimoto WY. Association between baseline plasma leptin levels and subsequent development of diabetes in Japanese Americans. Diabetes Care. 1999 Jan;22(1):65-70. doi: 10.2337/diacare.22.1.65.
Results Reference
background
PubMed Identifier
9519719
Citation
Chessler SD, Fujimoto WY, Shofer JB, Boyko EJ, Weigle DS. Increased plasma leptin levels are associated with fat accumulation in Japanese Americans. Diabetes. 1998 Feb;47(2):239-43. doi: 10.2337/diab.47.2.239.
Results Reference
background
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Central Obesity and Disease Risk in Japanese Americans
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