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Trial record 20 of 95 for:    Recruiting, Not yet recruiting, Available Studies | diabetes | NIDDK | ( Map: United States )

Natural History of Autoimmune Diabetes and Its Complications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00896610
Recruitment Status : Recruiting
First Posted : May 11, 2009
Last Update Posted : February 5, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:


  • 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.


  • 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.


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


  • 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 or disease
Type 1 Diabetes Type 2 Diabetes Immunologically Mediated Type 1 Diabetes Anti Beta-Cell Autoantibodies Autoimmunity

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. 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.

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Study Type : Observational
Estimated Enrollment : 99999999 participants
Time Perspective: Prospective
Official Title: Natural History of Autoimmune Diabetes and Its Complications
Actual Study Start Date : May 4, 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00896610

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Contact: Craig S Cochran, R.N. (301) 402-1880
Contact: Ranganath Muniyappa, M.D. (301) 451-7702

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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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Ranganath Muniyappa, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT00896610     History of Changes
Other Study ID Numbers: 090140
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: September 21, 2018

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

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