Clinical Trial: Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease

Brief Summary: Patients with GD often present with glucose dysregulation, which, according to most studies, is associated with islet β-cell dysfunctions, enhanced gluconeogenesis and insulin resistance (IR). Current studies focus mainly on IR, and a few that investigate islet β-cell functions show inconsistent results. This study examined the characteristics of glucose dysregulation in Chinese patients with GD, and furthermore evaluated the effects of thyroid dysfunction on islet β-cell functions and subsequently the carbohydrate metabolism.

Detailed Summary: Thyroid dysfunction is closely associated with glucoregulation. Carbohydrate metabolism can be affected with decreased levels of thyroid hormone (TH), even more so with an elevated TH level. Epidemiological data shows that 2%-57% of patients with Graves' Disease (GD) present with glucose dysregulation, which might also be related to the changes in islet β-cell functions in patients with GD. The incidence of GD has comparable variations geographically, with possibly different underlying mechanisms, such as an excessive intake of iodine resulting in an aggravation of autoimmune reactions from thyroid and consequently an increment in incidence of GD. The same might also be true in glucoregulation and islet β-cell functions in patients with GD. This study aims to examine the characteristics of glucoregulation and islet β-cell functions in patients with GD in different areas of China, using early-phase insulin secretion index (△I30/△G30), glucose area under curve(GAUC) and insulin area under curve(INSAUC).
Sponsor: Weikai Hou

Current Primary Outcome:

  • change from baseline blood glucose at 6 months [ Time Frame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment ]
  • change from baseline insulin at 6 months [ Time Frame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment ]
  • change from baseline thyroid hormone at 6 months [ Time Frame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment ]
  • change from baseline urine iodine concentration at 6 months [ Time Frame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Qilu Hospital of Shandong University

Dates:
Date Received: February 18, 2015
Date Started: June 2011
Date Completion:
Last Updated: February 24, 2015
Last Verified: February 2015