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

NCT02376088 | Completed

• 1 other identifier: GD-003
• Study Type: observational
• Target: 328
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Graves Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (7)

GA1

subjects from coastal areas who initiated Methimazole treatment for the first time on enrollment

Drug: Methimazole

GA2

subjects from coastal areas who were under Methimazole treatment and with an elevated TH level

Drug: Methimazole

GA3

subjects from coastal areas who were under Methimazole treatment and with a normal TH level

Drug: Methimazole

GB1

subjects from non-coastal areas who initiated Methimazole treatment for the first time on enrollment

Drug: Methimazole

GB2

subjects from non-coastal areas who were under Methimazole treatment and with an elevated TH level

Drug: Methimazole

GB3

subjects from non-coastal areas who were under Methimazole treatment and with a normal TH level

Drug: Methimazole

NC

age-matched healthy checkup subjects

Interventions

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.

Also known as: Thyrozol

GA1; GA2; GA3; GB1; GB2; GB3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weikai Hou: lead

MeSH Terms

Conditions

Graves Disease

Interventions

Methimazole

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 3, 2015
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 3, 2015

Record last verified: 2015-02