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

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ClinicalTrials.gov Identifier: NCT02376088
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Weikai Hou, Qilu Hospital of Shandong University

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.

Condition or disease Intervention/treatment
Graves Disease Drug: Methimazole

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).

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Study Type : Observational
Actual Enrollment : 328 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease
Study Start Date : June 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Methimazole

Group/Cohort Intervention/treatment
GA1
subjects from coastal areas who initiated Methimazole treatment for the first time on enrollment
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.
Other Name: Thyrozol

GA2
subjects from coastal areas who were under Methimazole treatment and with an elevated TH level
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.
Other Name: Thyrozol

GA3
subjects from coastal areas who were under Methimazole treatment and with a normal TH level
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.
Other Name: Thyrozol

GB1
subjects from non-coastal areas who initiated Methimazole treatment for the first time on enrollment
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.
Other Name: Thyrozol

GB2
subjects from non-coastal areas who were under Methimazole treatment and with an elevated TH level
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.
Other Name: Thyrozol

GB3
subjects from non-coastal areas who were under Methimazole treatment and with a normal TH level
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.
Other Name: Thyrozol

NC
age-matched healthy checkup subjects



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 283 outpatients, aged 22 to 55 years old(mean age 39±4 years), of whom 41 were male and 242 were female (M/F=1/5.90), were enrolled for the study from Qilu Hospital of Shandong University and Shandong Jiaotong Hospital between June, 2011 and June, 2014. An additional 45 age-matched healthy checkup subjects were included in the normal control group (NC). 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 were excluded.
Criteria

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

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Responsible Party: Weikai Hou, Professor, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT02376088     History of Changes
Other Study ID Numbers: GD-003
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases