Clinical trial NCT00005193: Prospective Study of Diabetes-related Vascular Disease in Oklahoma Indians
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus, Non-insulin Dependent
Diabetes Mellitus
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To study the relationship between diabetes and various macro- and microvascular complications in Oklahoma Indians.

Detailed description: BACKGROUND:

Diabetes is a major health hazard in Oklahoma Indians. A further important aspect is the apparently high vulnerability of the diabetic Oklahoma Indians to atherosclerotic disease. In the mid 1980s, this group had the highest prevalence of 0-wave changes on the electrocardiogram and amputation for ischemic gangrene of all 14 international samples in the World Health Organization Multinational Study. Its cardiovascular mortality rates were 2-3 times those of other national samples. An epidemic of coronary heart disease was attacking this Indian population.

Between 1973 and 1978, 1,085 adult Oklahoma Indians who were diagnosed with non-insulin dependent diabetes mellitus were recruited for a study on diabetes. The data from the study were used in part for the World Health Organization Multinational Study of Vascular Disease in Diabetes. The subjects were given a complete physical examination which included blood pressure, height, weight, electrocardiogram and detailed eye examination. Data were also collected on plasma cholesterol, plasma triglyceride, and proteinuria. Family histories and body weight were reviewed. The study followed this cohort.

DESIGN NARRATIVE:

This longitudinal study followed a previously studied cohort. Detailed baseline data collected in 1973-1978 were available. In phase I of the study, the life/death status of all 1,085 subjects was ascertained up to January 1, 1986. Death certificates were obtained and cause of death analyzed. For the survivors, a personal interview and physical examination were performed in Phase II. Occurrence of specified diabetes-related vascular complications was documented. The detailed follow-up questionnaire included all the data required for the WHO Multinational Study of Vascular Disease in Diabetes plus specific information related to this population. Analysis was conducted on overall mortality rates, disease-specific mortality rates, and survival time. Prevalence and incidence of morbidity from micro- and macrovascular complications were estimated. The extent to which selected risk factors were associated with or could predict the development of vascular diseases was examined. The results of the analyses were compared with those obtained in the WHO Multinational Study.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lee ET, Lee VS, Kingsley RM, Lu M, Russell D, Asal NR, Wilkinson CP, Bradford RH Jr. Diabetic retinopathy in Oklahoma Indians with NIDDM. Incidence and risk factors. Diabetes Care. 1992 Nov;15(11):1620-7. doi: 10.2337/diacare.15.11.1620.
citation: Lee ET, Lee VS, Lu M, Russell D. Development of proliferative retinopathy in NIDDM. A follow-up study of American Indians in Oklahoma. Diabetes. 1992 Mar;41(3):359-67. doi: 10.2337/diab.41.3.359.
citation: Lee ET, Lee VS, Lu M, Lee JS, Russell D, Yeh J. Incidence of renal failure in NIDDM. The Oklahoma Indian Diabetes Study. Diabetes. 1994 Apr;43(4):572-9. doi: 10.2337/diab.43.4.572.
citation: Lee VS, Kingsley RM, Lee ET, Lu M, Russell D, Asal NR, Bradford RH Jr, Wilkinson CP. The diagnosis of diabetic retinopathy. Ophthalmoscopy versus fundus photography. Ophthalmology. 1993 Oct;100(10):1504-12. doi: 10.1016/s0161-6420(93)31449-1.
citation: Lee JS, Lu M, Lee VS, Russell D, Bahr C, Lee ET. Lower-extremity amputation. Incidence, risk factors, and mortality in the Oklahoma Indian Diabetes Study. Diabetes. 1993 Jun;42(6):876-82. doi: 10.2337/diab.42.6.876.
citation: Lee ET, Russell D, Jorge N, Kenny S, Yu ML. A follow-up study of diabetic Oklahoma Indians. Mortality and causes of death. Diabetes Care. 1993 Jan;16(1):300-5. doi: 10.2337/diacare.16.1.300.