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

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.

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Key information

Conditions

Graves Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methimazole

Drug

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.

Other names: Thyrozol

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Weikai Hou

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Mar 3, 2015
Registry last updated: Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed