The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

Yonsei University

Status: Unknown

Conditions: Mild Graves' Ophthalmopathy

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02535975

4-2014-0706

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Metformin

Experimental group

Description:

Metformin 500mg PO three times a day for 24 weeks

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

Placebo tab. PO three times a day for 24 weeks

Treatment:

Drug: Placebo