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

Sponsor
Tianjin Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03525028
Collaborator
Peking Union Medical College Hospital (Other), Peking University First Hospital (Other), Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
138
1
2
50
2.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The incidence of abnormal metabolic indexes [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University Eye Hospital Tianjin Tianjin China 300000

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xiaomin Zhang, Director of the Tianjin Medical University Eye Institute,archiater, Tianjin Medical University
ClinicalTrials.gov Identifier:
NCT03525028
Other Study ID Numbers:
  • 2017KY-06
First Posted:
May 15, 2018
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022