The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

Mild Graves' Ophthalmopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02535975
• Other study ID #: 4-2014-0706
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: October 2019

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: Eun Jig Lee, MD, PhD
• Phone: +82-2-2228-1983
• Email: ejlee432[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Mild Graves' Ophthalmopathy

Intervention

Drug:
• Metformin
Tablets metformin 500 mg PO three times a day for 24 weeks
• Placebo
Tablets placebo PO three times a day for 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Endocrinology, Internal Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Clinical Activity Score (CAS) score	Comparison of CAS scores before and after treatment in each arm and an inter-arm	At 0, 6 and 12 months
Primary	Change of NOSPECS score	Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm.	At 0, 6 and 12 months
Secondary	adverse events	Comparison of adverse events rate in each arm and an inter-arm.	At 0, 6 and 12 months
Secondary	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.	At 0, 6 and 12 months