Natural History of Autoimmune Diabetes and Its Complications

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00896610
First received: May 8, 2009
Last updated: May 9, 2014
Last verified: April 2014

May 8, 2009
May 9, 2014
May 2009
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Complete list of historical versions of study NCT00896610 on ClinicalTrials.gov Archive Site
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Natural History of Autoimmune Diabetes and Its Complications
Natural History of Autoimmune Diabetes and Its Complications

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.

Individuals with known or suspected autoimmune mediated diabetes, or healthy individuals at risk for developing the disease, will be evaluated at the NIH Clinical Center. Studies will include characterizing the disease s clinical and laboratory features, observing the natural history of the disease and its complications, evaluating responses to standard treatments, designing assays to measure anti-insulin producing cell immune responses and pancreatic insulin producing cell function and number, and determining patients eligibility for other experimental diagnostic or therapeutic protocols. Protocol enrollees may be asked to contribute blood and/or urine samples for immunological research studies, and/or for studies designed to find parameters that increase a subject s risk for diabetes and/or its associated complications.

Observational
Time Perspective: Prospective
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  • Type 1 Diabetes
  • Type 2 Diabetes
  • Immunologically Mediated Type 1 Diabetes
  • Anti Beta-Cell Autoantibodies
  • Autoimmunity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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-INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Both
2 Years and older
Yes
Contact: Michelle L Ashmus, R.N. (301) 594-5953 ashmusm@mail.nih.gov
Contact: Ranganath Muniyappa, MD, PhD (301) 451-7702 muniyapr@mail.nih.gov
United States
 
NCT00896610
090140, 09-DK-0140
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Ranganath Muniyappa, MD, PhD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health Clinical Center (CC)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP