Prospective Study of Diabetes-related Vascular Disease in Oklahoma Indians

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005193
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: September 2002
  Purpose

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


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

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1986
Estimated Study Completion Date: August 1990
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005193     History of Changes
Other Study ID Numbers: 1072
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 31, 2014