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

May 5, 2022 updated by: Xiaomin Zhang, Tianjin Medical University

Multicenter, Randomized, Controlled Clinical Trial Research Evaluating the Use of Combination Therapy of Glucocorticoids and Metformin to Decrease Glucocorticoids Side Effects in Patients With Autoimmune Uveitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaomin Zhang, M.D.
  • Phone Number: +86-13920023990
  • Email: xiaomzh@126.com

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Medical University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Chronic and non-infectious autoimmune uveitis with systemic glucocorticoids treatment (Initiation dosage ≥ 1 mg/kg/d or ≥ 50 mg/d).
  3. 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).
  4. All genders, age ≥ 18 years old.
  5. Ready for systemic glucocorticoids treatment.
  6. Willing to follow all study requirements and sign the informed consent.
  7. Without history of cancer and serious systemic diseases.

Exclusion Criteria:

  1. Participate in other clinical trials within the preceding one years
  2. Planning ophthalmologic surgery over the next three months.
  3. With other sight-threatening diseases except cataract, such as glaucoma, diabetic retinopathy, retinal detachment, and so on.
  4. Taking or will take immunosuppressants which affecting glycometabolism and lipid metabolism except methotrexate,mycophenolate and azathioprine.
  5. Any known history of a serious infection (e.g., HIV, hepatitis, pneumonia, syphilis or tuberculosis).
  6. Any known history of diabetes mellitus, severe hepatic, renal or heart disease.
  7. Any known history of drug addiction, drug abuse and malignant tumor.
  8. Presence of a transplanted solid organ.
  9. Pregnant women and nursing mothers.
  10. Any known history of mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin group
Oral metformin 500 mg once daily for first week, 500 mg twice daily for next 23 weeks. The follow-up treatment according to the participants' condition.
Drug: Metformin
The investigators assumed that the combination therapy of metformin and glucocorticoids can decrease glucocorticoids side effects and synergia the anti-inflammatory and immune inhibitory effect of glucocorticoids. So the investigators use metformin in the experimental group.
Placebo Comparator: Placebo group
Oral placebo 500 mg once daily for first week, 500 mg twice daily for next 23 weeks. The follow-up treatment according to the participants' condition.
Drug: Placebo
The investigators use placebo in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of abnormal metabolic indexes
Time Frame: 24 weeks
The assessments of abnormal metabolic indexes include any of these outcome measures: FBG≥6.1 mmol/L, TC≥6.2 mmol/L (240 mg/d1), TG≥2.3 mmol/L (200 mg/dl) or BMI increased 1 kg/m^2 than before in the process of follow-up twice in a row.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University

Collaborators

Peking University First Hospital
Peking Union Medical College Hospital
Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

  • Study Director: Xiaorong Li, M.D., Tianjin Medical University Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

April 14, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017KY-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The study protocol,statistical analysis plan,informed consent form and clinical study report are to be shared with other researchers.

IPD Sharing Time Frame

The data will become available starting 6 months after publication.

IPD Sharing Access Criteria

The study protocol,statistical analysis plan,informed consent form and clinical study report are to be shared with other researchers.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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