search
Back to results

Prospective Study of Diabetes-related Vascular Disease in Oklahoma Indians

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00005193
    Brief Title
    Prospective Study of Diabetes-related Vascular Disease in Oklahoma Indians
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    September 2002
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1986 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 1990 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Diabetes Mellitus

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1468294
    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.
    Results Reference
    background
    PubMed Identifier
    1551496
    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.
    Results Reference
    background
    PubMed Identifier
    8138063
    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.
    Results Reference
    background
    PubMed Identifier
    8414411
    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.
    Results Reference
    background
    PubMed Identifier
    8495811
    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.
    Results Reference
    background
    PubMed Identifier
    8422796
    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.
    Results Reference
    background

    Learn more about this trial

    Prospective Study of Diabetes-related Vascular Disease in Oklahoma Indians

    We'll reach out to this number within 24 hrs