The Effects of Metformin in Patients With Mild Graves' Ophthalmopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02535975|
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mild Graves' Ophthalmopathy||Drug: Metformin Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Metformin 500mg PO three times a day for 24 weeks
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
Tablets placebo PO three times a day for 24 weeks
- 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
- 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.
- adverse events [ Time Frame: At 0, 6 and 12 months ]Comparison of adverse events rate in each arm and an inter-arm.
- 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.
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
|Contact: Eun Jig Lee, MD, PhDemail@example.com|
|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 firstname.lastname@example.org|