The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

NCT02535975 | Unknown

• 1 other identifier: 4-2014-0706
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• adverse events

  At 0, 6 and 12 months

• Quality of life questionnaires (GO-QoL)

  At 0, 6 and 12 months

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin 500mg PO three times a day for 24 weeks

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo tab. PO three times a day for 24 weeks

Drug: Placebo

Interventions

Metformin DRUG

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

Metformin

Placebo DRUG

Tablets placebo PO three times a day for 24 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Patients should not have diabetes (HbA1c level at screening should be lower than 6.5)
• Mild Graves' ophthalmopathy according to EUGOGO statement.
• Clinical activity score lower than 4
• Being euthyroid for at least 2 month before the enrollment
• No previous specific therapy for GO in 6 month before the enrollment except for local measures (e.g. eye drops)

You may not qualify if:

• Moderate-severe Graves' ophthalmopathy
• Clinical activity score ≥ 4
• 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
• Pregnant women
• Current use of metformin or containing preparations
• Metformin intolerance
• Inability to comply with the study protocol

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Endocrinology, Internal Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Eun Jig Lee, MD, PhD

CONTACT

+82-2-2228-1983; ejlee432@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 31, 2015
• Study Start: December 1, 2014
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

KR (1)