NCT03525028

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Tianjin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Uveitis
• Metformin
• Glucocorticoid

Interventions

Type	Name	Description
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.
DRUG	Placebo	The investigators use placebo in the control group.

Timeline

• Start date: 2018-11-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2018-05-15
• Last updated: 2022-05-06

Locations

1 site across 1 country: China