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临床试验/NCT00896610
NCT00896610终止不适用

Natural History of Autoimmune Diabetes and Its Complications

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2009年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
356
试验地点
1
主要终点
Blood glucose level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Blood glucose level

时间窗: every 3 months

Blood glucose level within a range appropriate for the patient's condition.

次要结局

未报告次要终点

研究者

研究点 (1)

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