Diabetes Mellitus, Type 2NCT01105858
Molecular and Clinical Profile of Diabetes Mellitus and Its Complications
An observational study of Diabetes Mellitus, Type 2 and Diabetic Nephropathy, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Family and twin studies have suggested that genetic factors influence approximately 50 percent of a person's susceptibility to type 2 diabetes. Recently, some of the genes involved in the development of type 2 diabetes have been identified, in large part by genome-wide association studies. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Nephropathy, Obesity
- How many people
- 2,310 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2010to not given
- Phase
- Observational
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenience sample, urban Phoenix
Who may be able to join
- Women and Men
- Individuals of any race (recruitment will focus on American Indians and Mexican Americans)
- 18 years and older
Who cannot join
- Pregnant Women
- Children under 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Background:
- Family and twin studies have suggested that genetic factors influence approximately 50 percent of a person's susceptibility to type 2 diabetes. Recently, some of the genes involved in the development of type 2 diabetes have been identified, in large part by genome-wide association studies. Certain risk factors for type 2 diabetes, such as obesity and insulin resistance, are highly inheritable, as are diabetic complications such as diabetes-related eye and kidney disorders. However, few genes associated or linked with diabetes risk factors or complications have been conclusively identified, and more research is needed to study specific genetic factors associated with these aspects of diabetes.
Read more
Objectives:
- To identify and characterize genetic variants associated with type 2 diabetes, its risk factors, and its complications.
Eligibility:
- Individuals at least 18 years of age who are not pregnant or nursing mothers at the start of the study.
Design:
- All participants will provide information about family history, ethnicity and ethnic background, occupation, behavioral risk factors, and other data as requested by the researchers.
- In addition to a general health history, participants will provide specific information about diabetes history, with particular emphasis on date of diagnosis, symptoms, initiation of insulin therapy, complications, and current medications.
- Testing procedures will be different for individuals with and without diabetes. Those without diabetes will have an oral glucose tolerance test, while those with diabetes will be examined for diabetic complications.
- Other tests during the study will include the following:
- Physical examination with measurements of height and weight, waist circumference, blood pressure, and other tests for individuals who have been diagnosed with diabetes
- Glucose tolerance test for those who have not been classified as having diabetes
- Retinal photographs
- Electrocardiograms
- Hepatic Ultrasound
- Blood and urine tests
- Depending on the results of the examination and laboratory findings, participants may be asked to return to the clinic for supplemental interviews, physical examinations, or blood tests, or to arrange referrals for medical evaluation and treatment.
- Participants who have diabetes will be asked to return for yearly follow-up visits. Participants who do not have diabetes at the initial examination will be asked to return for follow-up visits every 2 years.
Read the detailed description
Genetic factors play an important role in diabetes mellitus, its risk factors and complications, but most of the specific genetic determinants remain unidentified. The molecular pathways by which diabetes-susceptibility genes influence risk for diabetes and related conditions are also largely unknown. This project will seek to identify, and quantify the effects of, the genetic determinants of type 2 diabetes, its risk factors and complications in a multiethnic sample. Diabetes and glycemic status will be assessed from clinical interviews, an oral glucose tolerance test and glycated hemoglobin. Insulin sensitivity and insulin secretion will be assessed from indices derived from the oral glucose tolerance test. Other potential risk factors for type 2 diabetes (e.g., obesity) and its complications (e.g., retinopathy, nephropathy) will be measured. DNA will be collected and analyzed to identify genetic variants associated with or linked to diabetes or other traits. Studies of gene transcription, protein expression and metabolic profiling will be performed, and the resulting patterns will be analyzed for their relationships with diabetes, related traits and variants in diabetes susceptibility genes. Individuals will be studied longitudinally to determine if gene transcription, protein expression and metabolic profiles predict development of diabetes or its complications. These studies will help to determine the molecular pathways between genetic variants and susceptibility to type 2 diabetes and its complications.
- Conditions
- Diabetes Mellitus, Type 2, Diabetic Nephropathy, Obesity
- Keywords
- Diabetes Mellitus, Obesity, Diabetic Complications, Genetics, Molecular Profiling, Natural History
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Obesity, Diabetes Mellitus, Diabetes Complications
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 |
|---|---|---|
| Volunteers | Adult volunteers \& family members recruited from the Phoenix metropolitan area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes
Relationship of genotype and molecular/metabolic traits with diabetes and its complications or related traits
Measured: annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study start16 Nov 2010
Why it stopped: Recruitment temporarily paused.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 2,310 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
- NCT01105858
- Sponsor's protocol ID
- 999910091
- Other IDs
- 10-DK-N091
- Status last verified
- 19 Oct 2026
- First submitted
- 16 Apr 2010
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of laboratory tests and other data will be entered into the NIH patient chart, which is stored in a secure area, and stored in computer retrievable form. Retinal photographs will be stored securely in the Joslin Vision Network computer system located at Phoenix Indian Medical Center. All results will be treated to maintain participant confidentiality. Individual participants and pedigrees will not be identified in any publications resulting from the study. To protect confidentiality further, tribal affiliations will not be identified in publications.
Publications
Guo T, Hanson RL, Traurig M, Muller YL, Ma L, Mack J, Kobes S, Knowler WC, Bogardus C, Baier LJ. TCF7L2 is not a major susceptibility gene for type 2 diabetes in Pima Indians: analysis of 3,501 individuals. Diabetes. 2007 Dec;56(12):3082-8. doi: 10.2337/db07-0621. Epub 2007 Oct 1.
PubMed 17909099Hanson RL, Looker HC, Ma L, Muller YL, Baier LJ, Knowler WC. Design and analysis of genetic association studies to finely map a locus identified by linkage analysis: sample size and power calculations. Ann Hum Genet. 2006 May;70(Pt 3):332-49. doi: 10.1111/j.1529-8817.2005.00230.x.
PubMed 16674556Hanson RL, Pratley RE, Bogardus C, Narayan KM, Roumain JM, Imperatore G, Fagot-Campagna A, Pettitt DJ, Bennett PH, Knowler WC. Evaluation of simple indices of insulin sensitivity and insulin secretion for use in epidemiologic studies. Am J Epidemiol. 2000 Jan 15;151(2):190-8. doi: 10.1093/oxfordjournals.aje.a010187.
PubMed 10645822