Natural History of Autoimmune Diabetes and Its Complications
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|ClinicalTrials.gov Identifier: NCT00896610|
Recruitment Status : Terminated (All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data)
First Posted : May 11, 2009
Last Update Posted : October 8, 2020
- 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|
|Diabetes Mellitus Type 1 Diabetes Mellitus Type 2|
|Study Type :||Observational|
|Actual Enrollment :||356 participants|
|Official Title:||Natural History of Autoimmune Diabetes and Its Complications|
|Actual Study Start Date :||May 13, 2009|
|Actual Primary Completion Date :||September 30, 2020|
|Actual Study Completion Date :||September 30, 2020|
Individuals who have been diagnosed with or are at risk for developing diabetes
- Blood glucose level [ Time Frame: every 3 months ]Blood glucose level within a range appropriate for the patient's condition.
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 ClinicalTrials.gov identifier (NCT number): NCT00896610
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Ranganath Muniyappa, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|