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Molecular and Clinical Profile of Diabetes Mellitus and Its Complications

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ClinicalTrials.gov Identifier: NCT01105858
Recruitment Status : Recruiting
First Posted : April 19, 2010
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


- 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.


- To identify and characterize genetic variants associated with type 2 diabetes, its risk factors, and its complications.


- Individuals at least 18 years of age who are not pregnant or nursing mothers at the start of the study.


  • 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.

Condition or disease
Diabetes Mellitus, Type 2 Diabetic Nephropathy Obesity

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.

Study Design

Study Type : Observational
Estimated Enrollment : 999999 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Molecular and Clinical Profile of Diabetes Mellitus and Its Complications
Study Start Date : April 1, 2010
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Diabetes [ Time Frame: every 2 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • Women and Men
  • Individuals of any race (recruitment will focus on American Indians and Mexican Americans)
  • 18 years and older


  • Pregnant Women
  • Children under 18 years old
Contacts and Locations

Information from the National Library of Medicine

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): NCT01105858

Contact: Robert L Hanson, M.D. (602) 200-5207 rhanson@phx.niddk.nih.gov

United States, Arizona
NIDDK, Phoenix Recruiting
Phoenix, Arizona, United States, 85014
Contact: Robert Hanson, M.D.    602-200-5207    rhanson@phx.niddk.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Robert L Hanson, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01105858     History of Changes
Other Study ID Numbers: 999910091
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 24, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Diabetes Mellitus
Diabetic Complications
Molecular Profiling

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications