Clinical Trial: The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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.

Detailed Summary:
Sponsor: Yonsei University

Current Primary Outcome:

• 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
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• adverse events [ Time Frame: At 0, 6 and 12 months ]
  Comparison of adverse events rate in each arm and an inter-arm.
• 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.

Original Secondary Outcome: Same as current

Information By: Yonsei University

Dates:
Date Received: August 12, 2015
Date Started: December 2014
Date Completion: June 2017
Last Updated: August 26, 2015
Last Verified: August 2015