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The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy

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ClinicalTrials.gov Identifier: NCT02535975
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mild Graves' Ophthalmopathy Drug: Metformin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2014
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: Metformin
Metformin 500mg PO three times a day for 24 weeks
Drug: Metformin
Tablets metformin 500 mg PO three times a day for 24 weeks

Placebo Comparator: Placebo
Placebo tab. PO three times a day for 24 weeks
Drug: Placebo
Tablets placebo PO three times a day for 24 weeks




Primary Outcome Measures :
  1. Change of Clinical Activity Score (CAS) score [ Time Frame: At 0, 6 and 12 months ]
    Comparison of CAS scores before and after treatment in each arm and an inter-arm

  2. Change of NOSPECS score [ Time Frame: At 0, 6 and 12 months ]
    Comparison of NOSPECS scores before and after treatment in each arm and an inter-arm.


Secondary Outcome Measures :
  1. adverse events [ Time Frame: At 0, 6 and 12 months ]
    Comparison of adverse events rate in each arm and an inter-arm.

  2. Quality of life questionnaires (GO-QoL) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02535975


Contacts
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Contact: Eun Jig Lee, MD, PhD +82-2-2228-1983 ejlee432@yuhs.ac

Locations
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Korea, Republic of
Endocrinology, Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Eun Jig Lee, MD    +82-2-2228-1983    ejlee432@yuhs.ac   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02535975     History of Changes
Other Study ID Numbers: 4-2014-0706
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Graves Ophthalmopathy
Eye Diseases
Eye Diseases, Hereditary
Graves Disease
Orbital Diseases
Genetic Diseases, Inborn
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Exophthalmos
Goiter
Hyperthyroidism
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs