Natural History of Autoimmune Diabetes and Its Complications

NCT00896610 | Terminated

• 2 other identifiers: 09014009-DK-0140
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Diabetes is a disease defined by abnormally high blood sugar (glucose) levels. Glucose is an essential source of energy for the body s cells, but insulin is required to move the glucose into the cells. Insulin is a hormone produced by the pancreas that allows glucose to enter cells.
• In diabetes, the body is unable to supply enough insulin to meet its demands. The problem may be a low supply of insulin or a high demand for insulin. Someone who has been diagnosed with diabetes has lost much of their insulin-producing capacity. Clinical studies have shown that good control of blood sugar is essential to prevent diabetes complications like damage to the eyes, kidneys, nerves, and blood vessels. Objectives:
• To establish a relationship with several individuals with diabetes caused by the immune system attacking the body s insulin-producing cells in order to:
• Explore why the immune system attacks insulin-producing cells.
• Understand why some individuals develop diabetes-related complications and others do not.
• Develop therapies to improve how patients can control their blood sugar levels.
• Continue to follow subjects who have completed or are considering other NIH diabetes-related studies.
• To develop improved tests for determining an individual s risk for developing diabetes and/or to accurately diagnose the exact type of diabetes. Eligibility:
• Individuals who have been diagnosed with or are at risk for developing diabetes. Design:
• Standard physical examination and clinical tests to determine if the patient has diabetes or to confirm a particular type of diabetes:
• None of the treatment in this study is experimental.
• Patients will receive a separate consent form for any special tests needed to learn more about their particular type of diabetes.
• Patients may be asked to provide additional urine and blood samples for use in laboratory research about diabetes.
• Researchers may offer medical treatment advice for diabetes, or explain how to improve patients diabetes management skills.

Conditions

Diabetes Mellitus Type 1; Diabetes Mellitus Type 2

Keywords

Diabetes Type II; Diabetes Type 1; Autoimmunity; Type 1 Diabetes; Type 2 Diabetes; Autoimmune Diabetes; At Risk Diabetes

Outcome Measures

Primary Outcomes (1)

• Blood glucose level

  Blood glucose level within a range appropriate for the patient's condition.

  every 3 months

Study Arms (1)

Diabetes

Individuals who have been diagnosed with or are at risk for developing diabetes

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have been diagnosed with or are at risk for developing diabetes

You may qualify if:

• i. Clinical diagnosis of diabetes, either type 1 (T1D) or insulin-requiring type 2 (T2D),
• ii. Healthy individuals who may be at risk for developing diabetes,
• iii. Individuals with suspected immune mediated diabetes,
• iv. Willingness of the patient or guardian to give informed consent and assent.

You may not qualify if:

• i. Concomitant medical problems which would confound the interpretation studies of the autoimmune beta cell destructive process
• ii. Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.
• iii. Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Harlan DM, von Herrath M. Immune intervention with anti-CD3 in diabetes. Nat Med. 2005 Jul;11(7):716-8. doi: 10.1038/nm0705-716. No abstract available.

  PMID: 16015359 BACKGROUND

• Haines L, Wan KC, Lynn R, Barrett TG, Shield JP. Rising incidence of type 2 diabetes in children in the U.K. Diabetes Care. 2007 May;30(5):1097-101. doi: 10.2337/dc06-1813. Epub 2007 Jan 26.

  PMID: 17259470 BACKGROUND

• Palmer JP, Hampe CS, Chiu H, Goel A, Brooks-Worrell BM. Is latent autoimmune diabetes in adults distinct from type 1 diabetes or just type 1 diabetes at an older age? Diabetes. 2005 Dec;54 Suppl 2:S62-7. doi: 10.2337/diabetes.54.suppl_2.s62.

  PMID: 16306342 BACKGROUND

• Lo B, Swafford AD, Shafer-Weaver KA, Jerome LF, Rakhlin L, Mathern DR, Callahan CA, Jiang P, Davison LJ, Stevens HE, Lucas CL, White J, von Borstel R, Todd JA, Lenardo MJ. Antibodies against insulin measured by electrochemiluminescence predicts insulitis severity and disease onset in non-obese diabetic mice and can distinguish human type 1 diabetes status. J Transl Med. 2011 Nov 28;9:203. doi: 10.1186/1479-5876-9-203.

  PMID: 22123298 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases

Study Officials

• Ranganath Muniyappa, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 11, 2009
• Study Start: May 13, 2009
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)