Graves DiseaseNCT02376088
Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease
An observational study of Graves Disease, run by Weikai Hou.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Graves Disease
- What is being tested?
- Methimazole
- How many people
- 328 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Patients with Graves Disease
- Age-matched healthy checkup subjects
Who cannot join
- 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
About this study
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.
Read the 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).
- Conditions
- Graves Disease
- Being tested
- Methimazole
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethimazoleDrug
Also called Thyrozol
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.
| Study group | Role | What they receive |
|---|---|---|
| GA1 | subjects from coastal areas who initiated Methimazole treatment for the first time on enrollment Receives: Drug: Methimazole | |
| GA2 | subjects from coastal areas who were under Methimazole treatment and with an elevated TH level Receives: Drug: Methimazole | |
| GA3 | subjects from coastal areas who were under Methimazole treatment and with a normal TH level Receives: Drug: Methimazole | |
| GB1 | subjects from non-coastal areas who initiated Methimazole treatment for the first time on enrollment Receives: Drug: Methimazole | |
| GB2 | subjects from non-coastal areas who were under Methimazole treatment and with an elevated TH level Receives: Drug: Methimazole | |
| GB3 | subjects from non-coastal areas who were under Methimazole treatment and with a normal TH level Receives: Drug: Methimazole | |
| NC | age-matched healthy checkup subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline blood glucose at 6 months
Measured: 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
Measured: 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
Measured: 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
Measured: at the day of the subject's enrollment into the study(baseline) and at 6 months after the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJun 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weikai Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weikai Hou, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376088
- Sponsor's protocol ID
- GD-003
- Status last verified
- Feb 2015
- First submitted
- 18 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Islet β-cell Functions in Chinese Patients With Graves' Disease
- ClinicalTrials.gov ID
- NCT02376088
- Acronym / sponsor ID
- GD-003
- Conditions
- Graves Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Weikai HouUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| GA1 | – | Drug: Methimazolesubjects from coastal areas who initiated Methimazole treatment for the first time on enrollment |
| GA2 | – | Drug: Methimazolesubjects from coastal areas who were under Methimazole treatment and with an elevated TH level |
| GA3 | – | Drug: Methimazolesubjects from coastal areas who were under Methimazole treatment and with a normal TH level |
| GB1 | – | Drug: Methimazolesubjects from non-coastal areas who initiated Methimazole treatment for the first time on enrollment |
| GB2 | – | Drug: Methimazolesubjects from non-coastal areas who were under Methimazole treatment and with an elevated TH level |
| GB3 | – | Drug: Methimazolesubjects from non-coastal areas who were under Methimazole treatment and with a normal TH level |
| NC | – | –age-matched healthy checkup subjects |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients with Graves Disease
- Age-matched healthy checkup subjects
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethimazoleAlso: ThyrozolAll 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. | Drug | GA1, GA2, GA3, GB1, GB2, GB3 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease, run by Weikai Hou.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.