Diabetes Mellitus, Type 2NCT00339482
Prospective Studies of the Natural History of Diabetes Mellitus and Its Complications in the Gila River Indian Community
An observational study of Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 12,647 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 1976to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons aged 5 years and over residing in districts 1-5 of the Gila River Indian Community in Arizona.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Studies of Diabetes Mellitus and Its Complications in the Gila River Indian Community
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- AMERICAN INDIAN, Diabetes, Renal Diseases, Cardiovascular Disease, Natural History
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Kidney Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| American Indians | Residents of the Gila River Indian Community |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the determinants of type 2 diabetes and its complications.
Development of diabetes and related complications.
Measured: indefinite
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start3 Sep 1976
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,647 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Robert L Hanson, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00339482
- Sponsor's protocol ID
- 9999760256
- Other IDs
- OH76-DK-0256
- Status last verified
- 4 Nov 2026
- First submitted
- 19 Jun 2006
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wolford JK, Bogardus C, Prochazka M. Genome-wide scan for CAG/CTG repeat expansions in Pimas with early onset of type 2 diabetes mellitus. Mol Genet Metab. 1999 Jan;66(1):62-7. doi: 10.1006/mgme.1998.2775.
PubMed 9973549Lindsay RS, Dabelea D, Roumain J, Hanson RL, Bennett PH, Knowler WC. Type 2 diabetes and low birth weight: the role of paternal inheritance in the association of low birth weight and diabetes. Diabetes. 2000 Mar;49(3):445-9. doi: 10.2337/diabetes.49.3.445.
PubMed 10868967Silver K, Walston J, Yang Y, Pratley R, Ravussin E, Raben N, Shuldiner AR. Molecular scanning of the beta-3-adrenergic receptor gene in Pima Indians and Caucasians. Diabetes Metab Res Rev. 1999 May-Jun;15(3):175-80. doi: 10.1002/(sici)1520-7560(199905/06)15:33.0.co;2-y.
PubMed 10441039Aydin BN, Stinson EJ, Looker HC, Walter P, Cabeza de Baca T, Krakoff J, Chang DC. Cholecystectomy Is Linked With Lower Respiratory Exchange Ratio and Higher Lipid Oxidation and Sleep Energy Expenditure. Obesity (Silver Spring). 2026 Apr;34(4):793-800. doi: 10.1002/oby.70145. Epub 2026 Feb 12.
PubMed 41677021Aydin BN, Stinson EJ, Hanson RL, Looker HC, Cabeza De Baca T, Krakoff J, Chang DC. Hepatic Insulin Resistance Increases Risk of Gallstone Disease in Indigenous Americans in the Southwestern United States. Clin Transl Gastroenterol. 2024 Nov 1;15(11):e00763. doi: 10.14309/ctg.0000000000000763.
PubMed 39166750Mitchell CM, Stinson EJ, Chang DC, Krakoff J. A mixed meal tolerance test predicts onset of type 2 diabetes in Southwestern Indigenous adults. Nutr Diabetes. 2024 Jul 10;14(1):50. doi: 10.1038/s41387-024-00269-3.
PubMed 38987291Willig MR, Stinson EJ, Looker HC, Piaggi P, Mitchell CM, Hanson RL, Nelson RG, Krakoff J, Chang DC. Insulin resistance before type 2 diabetes onset is associated with increased risk of albuminuria after diabetes onset: A prospective cohort study. Diabetes Obes Metab. 2024 May;26(5):1888-1896. doi: 10.1111/dom.15505. Epub 2024 Feb 28.
PubMed 38419421Stinson EJ, Mitchell CM, Looker HC, Krakoff J, Chang DC. Higher glucose and insulin responses to a mixed meal are associated with increased risk of diabetic retinopathy in Indigenous Americans. J Endocrinol Invest. 2024 Mar;47(3):699-707. doi: 10.1007/s40618-023-02187-0. Epub 2023 Sep 9.
PubMed 37684485Shah MH, Piaggi P, Looker HC, Paddock E, Krakoff J, Chang DC. Lower insulin clearance is associated with increased risk of type 2 diabetes in Native Americans. Diabetologia. 2021 Apr;64(4):914-922. doi: 10.1007/s00125-020-05348-5. Epub 2021 Jan 6.
PubMed 33404681Hohenadel MG, Baier LJ, Piaggi P, Muller YL, Hanson RL, Krakoff J, Thearle MS. The impact of genetic variants on BMI increase during childhood versus adulthood. Int J Obes (Lond). 2016 Aug;40(8):1301-9. doi: 10.1038/ijo.2016.53. Epub 2016 Apr 14.
PubMed 27076275Hohenadel MG, Thearle MS, Grice BA, Huang H, Dai MH, Tao YX, Hunter LA, Palaguachi GI, Mou Z, Kim RC, Tsang MM, Haack K, Voruganti VS, Cole SA, Butte NF, Comuzzie AG, Muller YL, Baier LJ, Krakoff J, Knowler WC, Yanovski JA, Han JC. Brain-derived neurotrophic factor in human subjects with function-altering melanocortin-4 receptor variants. Int J Obes (Lond). 2014 Aug;38(8):1068-74. doi: 10.1038/ijo.2013.221. Epub 2013 Nov 26.
PubMed 24276017
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Studies of Diabetes Mellitus and Its Complications in the Gila River Indian Community
- ClinicalTrials.gov ID
- NCT00339482
- Acronym / sponsor ID
- 9999760256
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- AMERICAN INDIAN, Diabetes, Renal Diseases, Cardiovascular Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,647 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 3 Sep 1976 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| American Indians | – | –Residents of the Gila River Indian Community |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons aged 5 years and over residing in districts 1-5 of the Gila River Indian Community in Arizona.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To investigate the determinants of type 2 diabetes and its complications.
Time frame: indefinite
Development of diabetes and related complications.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 9973549Wolford JK, Bogardus C, Prochazka M. Genome-wide scan for CAG/CTG repeat expansions in Pimas with early onset of type 2 diabetes mellitus. Mol Genet Metab. 1999 Jan;66(1):62-7. doi: 10.1006/mgme.1998.2775.
- Background: PubMed 10868967Lindsay RS, Dabelea D, Roumain J, Hanson RL, Bennett PH, Knowler WC. Type 2 diabetes and low birth weight: the role of paternal inheritance in the association of low birth weight and diabetes. Diabetes. 2000 Mar;49(3):445-9. doi: 10.2337/diabetes.49.3.445.
- Background: PubMed 10441039Silver K, Walston J, Yang Y, Pratley R, Ravussin E, Raben N, Shuldiner AR. Molecular scanning of the beta-3-adrenergic receptor gene in Pima Indians and Caucasians. Diabetes Metab Res Rev. 1999 May-Jun;15(3):175-80. doi: 10.1002/(sici)1520-7560(199905/06)15:33.0.co;2-y.
- Derived from this study: PubMed 41677021Aydin BN, Stinson EJ, Looker HC, Walter P, Cabeza de Baca T, Krakoff J, Chang DC. Cholecystectomy Is Linked With Lower Respiratory Exchange Ratio and Higher Lipid Oxidation and Sleep Energy Expenditure. Obesity (Silver Spring). 2026 Apr;34(4):793-800. doi: 10.1002/oby.70145. Epub 2026 Feb 12.
- Derived from this study: PubMed 39166750Aydin BN, Stinson EJ, Hanson RL, Looker HC, Cabeza De Baca T, Krakoff J, Chang DC. Hepatic Insulin Resistance Increases Risk of Gallstone Disease in Indigenous Americans in the Southwestern United States. Clin Transl Gastroenterol. 2024 Nov 1;15(11):e00763. doi: 10.14309/ctg.0000000000000763.
- Derived from this study: PubMed 38987291Mitchell CM, Stinson EJ, Chang DC, Krakoff J. A mixed meal tolerance test predicts onset of type 2 diabetes in Southwestern Indigenous adults. Nutr Diabetes. 2024 Jul 10;14(1):50. doi: 10.1038/s41387-024-00269-3.
- Derived from this study: PubMed 38419421Willig MR, Stinson EJ, Looker HC, Piaggi P, Mitchell CM, Hanson RL, Nelson RG, Krakoff J, Chang DC. Insulin resistance before type 2 diabetes onset is associated with increased risk of albuminuria after diabetes onset: A prospective cohort study. Diabetes Obes Metab. 2024 May;26(5):1888-1896. doi: 10.1111/dom.15505. Epub 2024 Feb 28.
- Derived from this study: PubMed 37684485Stinson EJ, Mitchell CM, Looker HC, Krakoff J, Chang DC. Higher glucose and insulin responses to a mixed meal are associated with increased risk of diabetic retinopathy in Indigenous Americans. J Endocrinol Invest. 2024 Mar;47(3):699-707. doi: 10.1007/s40618-023-02187-0. Epub 2023 Sep 9.
- Derived from this study: PubMed 33404681Shah MH, Piaggi P, Looker HC, Paddock E, Krakoff J, Chang DC. Lower insulin clearance is associated with increased risk of type 2 diabetes in Native Americans. Diabetologia. 2021 Apr;64(4):914-922. doi: 10.1007/s00125-020-05348-5. Epub 2021 Jan 6.
- Derived from this study: PubMed 27076275Hohenadel MG, Baier LJ, Piaggi P, Muller YL, Hanson RL, Krakoff J, Thearle MS. The impact of genetic variants on BMI increase during childhood versus adulthood. Int J Obes (Lond). 2016 Aug;40(8):1301-9. doi: 10.1038/ijo.2016.53. Epub 2016 Apr 14.
- Derived from this study: PubMed 24276017Hohenadel MG, Thearle MS, Grice BA, Huang H, Dai MH, Tao YX, Hunter LA, Palaguachi GI, Mou Z, Kim RC, Tsang MM, Haack K, Voruganti VS, Cole SA, Butte NF, Comuzzie AG, Muller YL, Baier LJ, Krakoff J, Knowler WC, Yanovski JA, Han JC. Brain-derived neurotrophic factor in human subjects with function-altering melanocortin-4 receptor variants. Int J Obes (Lond). 2014 Aug;38(8):1068-74. doi: 10.1038/ijo.2013.221. Epub 2013 Nov 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert L Hanson, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the determinants of type 2 diabetes and its complications. (time frame: indefinite). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00339482, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.