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

Graves Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376088
• Other study ID #: GD-003
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: February 24, 2015
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: Qilu Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with Graves Disease

• Age-matched healthy checkup subjects

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Graves Disease

Intervention

Drug:
• Methimazole
All enrolled subjects with GD were treated with methimazole. The initial dose for the GA1 and GB1 sungroups were 30 mg/d (10 mg, tid), TH levels were tested every month, and the dose was titrated accordingly over a period of 2-3 months, the dose was then decreased to 15-20 mg/d and thyroid function was monitored periodically until it eventually reached the maintenance dose of 2.5 mg-5.0 mg/d. The dose and adjustment method for GA2 and GB2 were the same with GA1 and GB1, while the dose for GA3 and GB3 was gradually decreased to 2.5-5.0 mg/d. All subjects underwent a treatment course over a period of 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Weikai Hou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No