The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

NCT ID: NCT02535975

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-10-31

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.

Conditions

Mild Graves' Ophthalmopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metformin

Metformin 500mg PO three times a day for 24 weeks

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Tablets metformin 500 mg PO three times a day for 24 weeks

Placebo

Placebo tab. PO three times a day for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets placebo PO three times a day for 24 weeks

Interventions

Metformin

Tablets metformin 500 mg PO three times a day for 24 weeks

Intervention Type: DRUG

Placebo

Tablets placebo PO three times a day for 24 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Endocrinology, Internal Medicine, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Eun Jig Lee, MD, PhD

Role: CONTACT

ejlee432@yuhs.ac

+82-2-2228-1983

Facility Contacts

Eun Jig Lee, MD

Role: primary

ejlee432@yuhs.ac

+82-2-2228-1983

Other Identifiers

4-2014-0706

Identifier Type: -

Identifier Source: org_study_id