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
  Purpose

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.

Condition
Type 1 Diabetes
Type 2 Diabetes
Immunologically Mediated Type 1 Diabetes
Anti Beta-Cell Autoantibodies
Autoimmunity

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Natural History of Autoimmune Diabetes and Its Complications

Resource links provided by NLM:


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

Estimated Enrollment: 99999999
Study Start Date: May 2009
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

-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.

  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: NCT00896610

Contacts
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

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Ranganath Muniyappa, MD, PhD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00896610     History of Changes
Other Study ID Numbers: 090140, 09-DK-0140
Study First Received: May 8, 2009
Last Updated: May 9, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Diabetes Mellitus
Type 1 Diabetes
Complications
Anti Beta-Cell Autoantibodies
T-Lymphocyte Assays
Type 2 Diabetes
Autoimmune Diabetes
At Risk Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014