Natural History of Autoimmune Diabetes and Its Complications
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 2/7/2019 |
| Start Date: | May 4, 2009 |
| Contact: | Craig S Cochran, R.N. |
| Email: | craigc@bdg10.niddk.nih.gov |
| Phone: | (301) 402-1880 |
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.
- 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.
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.
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.
-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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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