Trial record 8 of 1190 for:    NIDDK

Molecular and Clinical Profile of Diabetes Mellitus and Its Complications

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01105858
First received: April 16, 2010
Last updated: June 17, 2014
Last verified: May 2014
  Purpose

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.

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
  • 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
Diabetes Mellitus, Type 2
Diabetic Nephropathy
Obesity

Study Type: Observational
Official Title: Molecular and Clinical Profile of Diabetes Mellitus and Its Complications

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Diabetes [ Time Frame: every 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 99999999
Study Start Date: March 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Women and Men
  • Individuals of any race (recruitment will focus on American Indians and Mexican Americans)
  • 18 years and older

EXCLUSION CRITERIA:

  • Pregnant Women
  • Children under 18 years old
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105858

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

Locations
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
Investigators
Principal Investigator: Robert L Hanson, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01105858     History of Changes
Other Study ID Numbers: 999910091, 10-DK-N091
Study First Received: April 16, 2010
Last Updated: June 17, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diabetes Mellitus
Obesity
Diabetic Complications
Genetics
Molecular Profiling

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Obesity
Body Weight
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014