The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

January 29, 2019 updated by: Yonsei University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Eun Jig Lee, MD, PhD
  • Phone Number: +82-2-2228-1983
  • Email: ejlee432@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Endocrinology, Internal Medicine, Yonsei University College of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Metformin 500mg PO three times a day for 24 weeks
Drug: Metformin
Tablets metformin 500 mg PO three times a day for 24 weeks
Placebo Comparator: Placebo
Placebo tab. PO three times a day for 24 weeks
Drug: Placebo
Tablets placebo PO three times a day for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Clinical Activity Score (CAS) score
Time Frame: At 0, 6 and 12 months
Comparison of CAS scores before and after treatment in each arm and an inter-arm
At 0, 6 and 12 months
Change of NOSPECS score
Time Frame: At 0, 6 and 12 months
Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm.
At 0, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: At 0, 6 and 12 months
Comparison of adverse events rate in each arm and an inter-arm.
At 0, 6 and 12 months
Quality of life questionnaires (GO-QoL)
Time Frame: At 0, 6 and 12 months
Comparison of Graves' ophthalmopathy Quality of life questionnaire (GO-QOL) scores before and after treatment in each arm and an inter-arm.
At 0, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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