Clinical trial NCT02376088: Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease
Official title: Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves Disease
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: change from baseline blood glucose at 6 months
timeFrame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
measure: change from baseline insulin at 6 months
timeFrame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
measure: change from baseline thyroid hormone at 6 months
timeFrame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
measure: change from baseline urine iodine concentration at 6 months
timeFrame: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
Secondary outcomes:
Other outcomes:
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