- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005365
Central Obesity and Disease Risk in Japanese Americans
Study Overview
Status
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Wilfred Fujimoto, University of Washington
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Coronary Disease
- Heart Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Cardiovascular Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Obesity
- Metabolic Syndrome
- Insulin Resistance
- Hyperinsulinism
- Arteriosclerosis
- Atherosclerosis
Other Study ID Numbers
- 4252
- R01HL049293 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States