Genetic Influence on Susceptibility to Type 1 Diabetes Mellitus

NCT00001985 | Completed

• 2 other identifiers: 00006300-DK-0063
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes mellitus is an autoimmune disease in which the body's immune cells attack the insulin-producing cells of the pancreas. Several environmental and genetic factors may predispose individuals to developing this disease, including changes in a gene called CD152. This study will examine how this gene may influence the development of insulin-dependent diabetes. Patients with Type 1 diabetes mellitus enrolled in clinical trials at the National Institutes of Health and at the University of Florida and healthy normal volunteers may participate in this study. Participants will have up to three blood samples drawn over a period of less than 1 year. The first sample (about 20 milliliters, or 4 teaspoons), will be examined for changes in the structure of the CD152 gene. If the CD152 structure is different from that normally seen in the general population, a second sample (about 90 ml, or 6 tablespoons of blood) will be drawn. This sample will be used to study the function of specialized immune system cells (T cells), including their growth and survival, chemicals they produce when stimulated, and other factors. If these cells function differently from what is generally seen in the population, a third sample (90 ml) will be drawn for more detailed studies. This investigation may help explain what makes certain individuals susceptible to Type 1 diabetes mellitus and may contribute to the development of improved treatments for the disease.

Conditions

Diabetes Mellitus; Healthy

Keywords

Diabetes; Gene

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Patients must have a willingness and legal ability to give consent, or permission. Candidates with T1DM or Healthy Volunteers will be eligible. Patients must be equal to or greater than 18 years of age. Patients must not have an active malignancy. Patients with a hemoglobin count of less than 9.0 mg/dl will be excluded. Patients may be on erythropoietin therapy, but will not be placed on therapy solely to facilitate research sample acquisition. Patients must not have a known immunodeficiency syndrome.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Atkinson MA, Maclaren NK. The pathogenesis of insulin-dependent diabetes mellitus. N Engl J Med. 1994 Nov 24;331(21):1428-36. doi: 10.1056/NEJM199411243312107. No abstract available.

  PMID: 7969282 BACKGROUND

• Tisch R, McDevitt H. Insulin-dependent diabetes mellitus. Cell. 1996 May 3;85(3):291-7. doi: 10.1016/s0092-8674(00)81106-x. No abstract available.

  PMID: 8616883 BACKGROUND

• Rossini AA, Mordes JP, Like AA. Immunology of insulin-dependent diabetes mellitus. Annu Rev Immunol. 1985;3:289-320. doi: 10.1146/annurev.iy.03.040185.001445.

  PMID: 3904771 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 26, 2000
• First Posted: January 27, 2000
• Study Start: January 1, 2000
• Study Completion: February 1, 2003
• Last Updated: March 5, 2008

Record last verified: 2003-02

Locations

US (1)