The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

Not Applicable

• Conditions: Mild Graves' Ophthalmopathy
• Interventions: Drug: Metformin; Drug: Placebo

• Registration Number: NCT02535975
• Lead Sponsor: Yonsei University

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 Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-08-12
• Study First Submitted QC: 2015-08-26
• Study First Posted: 2015-08-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-30
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Metformin 500mg PO three times a day for 24 weeks
Placebo	Placebo	Placebo tab. PO three times a day for 24 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality of life questionnaires (GO-QoL)	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.
adverse events	At 0, 6 and 12 months	Comparison of adverse events rate in each arm and an inter-arm.

Trial Locations

Locations (1)

Endocrinology, Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of