NCT00896610

Natural History of Autoimmune Diabetes and Its Complications

Terminated Last updated 8 October 2020

What this trial tests

trial in Diabetes Mellitus Type 1 in 356 participants. Terminated before completion.

Timeline

13 May 2009

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	356
Start date	13 May 2009
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across United States

Conditions studied

• Diabetes Mellitus Type 1 — all drugs for Diabetes Mellitus Type 1 →
• Diabetes Mellitus Type 2 — all drugs for Diabetes Mellitus Type 2 →

Sponsor

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

Who can join

2 and older, any sex, with Diabetes Mellitus Type 1 or Diabetes Mellitus Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antibodies against insulin measured by electrochemiluminescence predicts insulitis severity and disease onset in non-obese diabetic mice and can distinguish human type 1 diabetes status.
   Lo B, Swafford AD, Shafer-Weaver KA, Jerome LF, et al · · 2011 · cited 20× · PMID 22123298 · DOI 10.1186/1479-5876-9-203