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

Completed

• Conditions: Graves Disease
• Interventions: Drug: Methimazole

• Registration Number: NCT02376088
• Lead Sponsor: Weikai Hou

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 Description

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).

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-02
• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-02-24
• Last Update Submitted: 2015-02-24
• Study First Posted: 2015-03-03
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 328

Inclusion Criteria

• Patients with Graves Disease
• Age-matched healthy checkup subjects

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Exclusion Criteria

• Patients with a medical history of diabetes, pancreatitis and other related conditions and positive family histories as well as medication history of glucocorticoid and anti-diabetic agents

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GA1	Methimazole	subjects from coastal areas who initiated Methimazole treatment for the first time on enrollment
GA2	Methimazole	subjects from coastal areas who were under Methimazole treatment and with an elevated TH level
GA3	Methimazole	subjects from coastal areas who were under Methimazole treatment and with a normal TH level
GB3	Methimazole	subjects from non-coastal areas who were under Methimazole treatment and with a normal TH level
GB2	Methimazole	subjects from non-coastal areas who were under Methimazole treatment and with an elevated TH level
GB1	Methimazole	subjects from non-coastal areas who initiated Methimazole treatment for the first time on enrollment

Primary Outcome Measures

Name	Time	Method
change from baseline blood glucose at 6 months	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	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	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	at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment