A Clinical Trial of Metformin to Decrease Glucocorticoids Side Effects in Patients With Autoimmune Uveitis

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    138
  • sponsor
    Tianjin Medical University
Updated on 17 May 2022
cancer
glucocorticoids
autoimmune uveitis

Summary

This project is designed to evaluating the use of combination therapy of glucocorticoid and metformin to decrease glucocorticoid side effects in participants with autoimmune uveitis.This study also aims to evaluate the anti-inflammatory and immunosuppressive effects of combination therapy.

Description

Approval of the study was obtained from the hospital's ethical committee. The study design and methodology followed the tenets of Declaration of Helsinki. All participants were provided with written informed consent and received a thorough explanation of the study design, aims, and the side effect of metformin. This is a multicenter, randomized, controlled clinical trial research. According to 1:1 ratio, all participants are randomly divided into two groups, the metformin group and placebo group.

According to the fasting blood glucose (FBG), triglycerides (TG),total cholesterol (TC) and body mass index (BMI), the investigators compared experimental group with control group to evaluate whether the use of combination therapy of glucocorticoid and metformin decrease glucocorticoid side effects in participants with autoimmune uveitis.

According to best corrected visual acuity (BCVA), anterior chamber and vitreous inflammation, fluorescence fundus angiography (FFA), electroretinogram (ERG) and so on, the investigators evaluate the anti-inflammatory and immunosuppressive effects of metformin in treatment of autoimmune uveitis.

Details
Condition Uveitis, Metformin, Glucocorticoid
Treatment Placebo, Metformin
Clinical Study IdentifierNCT03525028
SponsorTianjin Medical University
Last Modified on17 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Attending Tianjin Medical University Eye Hospital, ophthalmology department of Peking Union Medical College Hospital, ophthalmology department of Peking University First Hospital and Zhongshan Ophthalmic Center Sun Yat-sen University from January 2018 to January 2022
Chronic and non-infectious autoimmune uveitis with systemic glucocorticoids treatment (Initiation dosage ≥ 1 mg/kg/d or ≥ 50 mg/d)
FBG < 6.1 mmol/L, HbAlc<6.O%, TC <6.2 mmol/L(240 mg/d1) and TG <2.3 mmol/L(200 mg/dl)
All genders, age ≥ 18 years old
Ready for systemic glucocorticoids treatment
Willing to follow all study requirements and sign the informed consent
Without history of cancer and serious systemic diseases

Exclusion Criteria

Participate in other clinical trials within the preceding one years
Planning ophthalmologic surgery over the next three months
With other sight-threatening diseases except cataract, such as glaucoma, diabetic retinopathy, retinal detachment, and so on
Taking or will take immunosuppressants which affecting glycometabolism and lipid metabolism except methotrexate,mycophenolate and azathioprine
Any known history of a serious infection (e.g., HIV, hepatitis, pneumonia, syphilis or tuberculosis)
Any known history of diabetes mellitus, severe hepatic, renal or heart disease
Any known history of drug addiction, drug abuse and malignant tumor
Presence of a transplanted solid organ
Pregnant women and nursing mothers
Any known history of mental disorders
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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