Prospective Studies of the Natural History of Diabetes Mellitus and Its Complications in the Gila River Indian Community
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| ClinicalTrials.gov Identifier: NCT00339482 |
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Recruitment Status :
Completed
First Posted : June 21, 2006
Last Update Posted : June 24, 2022
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This project is a continuation of an extensive longitudinal population-based epidemiological investigation of the etiology and determinants of type 2 diabetes (and its complications) and formerly arthritis. The original baseline observations were made on the residents of the Gila Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the population at two-yearly intervals, and have continued to recruit new respondents who, because of age and residence or familial relationships, become eligible for entry into the project. Eligible persons receive a battery of standardized examinations related to diabetes and its complications at two-yearly intervals, including a glucose tolerance test, biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a physical examination, and in those aged 15 years and above, retinal photographs, and an electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at annual intervals to enable more complete and accurate documentation of their health status and to identify the development and progression of complications of the disease.
The data collected have been used to describe the natural history and determinants of diabetes and its complications, to investigate factors relating to the etiology of these diseases and investigate the genetics of diabetes, its complications and other phenotypes. In addition, the project serves to identify subjects with specific characteristics for the clinical research projects carried out by the Obesity and Diabetes Clinical Research Section and the Diabetes Epidemiology and Clinical Research Section fo the Branch.
| Condition or disease |
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| Diabetes Mellitus, Type 2 |
This project is a continuation of an extensive longitudinal population-based epidemiological investigation of the etiology and determinants of type 2 diabetes (and its complications) and formerly arthritis. The original baseline observations were made on the residents of the Gila Indian Reservation, predominantly Pima Indians, in 1965. We attempt to reexamine the population at two-yearly intervals, and have continued to recruit new respondents who, because of age and residence or familial relationships, become eligible for entry into the project. Eligible persons receive a battery of standardized examinations related to diabetes and its complications at two-yearly intervals, including a glucose tolerance test, biochemical determinations, such as serum cholesterol and creatinine, insulin, etc., a physical examination, and in those aged 15 years and above, retinal photographs, and an electrocardiogram. Persons known to have diabetes will be asked to undergo the examination at annual intervals to enable more complete and accurate documentation of their health status and to identify the development and progression of complications of the disease.
The data collected have been used to describe the natural history and determinants of diabetes and its complications, to investigate factors relating to the etiology of these diseases and investigate the genetics of diabetes, its complications and other phenotypes. In addition, the project serves to identify subjects with specific characteristics for the clinical research projects carried out by the Obesity and Diabetes Clinical Research Section and the Diabetes Epidemiology and Clinical Research Section of the Branch.
| Study Type : | Observational |
| Actual Enrollment : | 12647 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prospective Studies of Diabetes Mellitus and Its Complications in the Gila River Indian Community |
| Actual Study Start Date : | September 3, 1976 |
| Group/Cohort |
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American Indians
Residents of the Gila River Indian Community
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- To investigate the determinants of type 2 diabetes and its complications. [ Time Frame: indefinite ]Development of diabetes and related complications.
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| Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- INCLUSION CRITERIA:
The study population is all persons aged 5 years and over residing on the Gila River Indian Reservation in Arizona. The vast majority of the eligible subjects are American Indians and there are similar numbers of males and females in the population. The study population was chosen because our previous work has shown that this population has the highest prevalence of Type 2 diabetes in the world. There are small numbers of other racial groups in the selected population who are also eligible to participate in the study. They are mainly members of the families in the community and therefore by participating they can contribute valuable research information to the study. All persons resident in the community aged 5 years and over are invited to participate in the study at two-yearly intervals. In addition, other tribal members and selected family members such as first or second degree relatives of the study population who reside, or have moved off the Reservation, are also eligible to participate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00339482
| United States, Arizona | |
| NIDDK, Phoenix | |
| Phoenix, Arizona, United States, 85014 | |
| Principal Investigator: | Robert L Hanson, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00339482 |
| Other Study ID Numbers: |
9999760256 OH76-DK-0256 |
| First Posted: | June 21, 2006 Key Record Dates |
| Last Update Posted: | June 24, 2022 |
| Last Verified: | June 6, 2022 |
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AMERICAN INDIAN Diabetes Renal Diseases Cardiovascular Disease Natural History |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |