Natural History of Autoimmune Diabetes and Its Complications

Stopped early

Conditions studied: Diabetes Mellitus Type 1, Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00896610

Run by

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

People needed

356

Starts

2009-05-13

Expected to finish

2020-09-30

Last updated by the study team

2020-10-08

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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