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The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

Primary Purpose

Mild Graves' Ophthalmopathy

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Graves' Ophthalmopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-80 years
  2. Patients should not have diabetes (HbA1c level at screening should be lower than 6.5)
  3. Mild Graves' ophthalmopathy according to EUGOGO statement.
  4. Clinical activity score lower than 4
  5. Being euthyroid for at least 2 month before the enrollment
  6. No previous specific therapy for GO in 6 month before the enrollment except for local measures (e.g. eye drops)

Exclusion Criteria:

  1. Moderate-severe Graves' ophthalmopathy
  2. Clinical activity score ≥ 4
  3. Contraindication for metformin use as following: renal dysfunction (creatinine level should be within normal range), liver dysfunction (AST and ALT levels should be within normal range), severe concomitant illness
  4. Pregnant women
  5. Current use of metformin or containing preparations
  6. Metformin intolerance
  7. Inability to comply with the study protocol

Sites / Locations

  • Endocrinology, Internal Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Metformin 500mg PO three times a day for 24 weeks

Placebo tab. PO three times a day for 24 weeks

Outcomes

Primary Outcome Measures

Change of Clinical Activity Score (CAS) score
Comparison of CAS scores before and after treatment in each arm and an inter-arm
Change of NOSPECS score
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm.

Secondary Outcome Measures

adverse events
Comparison of adverse events rate in each arm and an inter-arm.
Quality of life questionnaires (GO-QoL)
Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm.

Full Information

First Posted
August 12, 2015
Last Updated
January 29, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02535975
Brief Title
The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized, double-blind, placebo-controlled study about the effect of metformin in patients with mild Graves' ophthalmopathy. Eighty patients with mild ophthalmopathy will be included. Each patient will be given either metformin (500mg PO three times a day) or placebo ( PO three times a day ) for 6 months and then followed for 6 months after withdrawal of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Graves' Ophthalmopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Metformin 500mg PO three times a day for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tab. PO three times a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Tablets metformin 500 mg PO three times a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets placebo PO three times a day for 24 weeks
Primary Outcome Measure Information:
Title
Change of Clinical Activity Score (CAS) score
Description
Comparison of CAS scores before and after treatment in each arm and an inter-arm
Time Frame
At 0, 6 and 12 months
Title
Change of NOSPECS score
Description
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm.
Time Frame
At 0, 6 and 12 months
Secondary Outcome Measure Information:
Title
adverse events
Description
Comparison of adverse events rate in each arm and an inter-arm.
Time Frame
At 0, 6 and 12 months
Title
Quality of life questionnaires (GO-QoL)
Description
Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm.
Time Frame
At 0, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-80 years Patients should not have diabetes (HbA1c level at screening should be lower than 6.5) Mild Graves' ophthalmopathy according to EUGOGO statement. Clinical activity score lower than 4 Being euthyroid for at least 2 month before the enrollment No previous specific therapy for GO in 6 month before the enrollment except for local measures (e.g. eye drops) Exclusion Criteria: Moderate-severe Graves' ophthalmopathy Clinical activity score ≥ 4 Contraindication for metformin use as following: renal dysfunction (creatinine level should be within normal range), liver dysfunction (AST and ALT levels should be within normal range), severe concomitant illness Pregnant women Current use of metformin or containing preparations Metformin intolerance Inability to comply with the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Jig Lee, MD, PhD
Phone
+82-2-2228-1983
Email
ejlee432@yuhs.ac
Facility Information:
Facility Name
Endocrinology, Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Jig Lee, MD
Phone
+82-2-2228-1983
Email
ejlee432@yuhs.ac

12. IPD Sharing Statement

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The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

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