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

Primary Purpose

Uveitis, Metformin, Glucocorticoid

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Metformin

Placebo

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tianjin Medical University Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The incidence of abnormal metabolic indexes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03525028

First Posted

April 14, 2018

Last Updated

May 5, 2022

Sponsor

Tianjin Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03525028

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

January 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tianjin Medical University

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis, Metformin, Glucocorticoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Metformin group

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The investigators use placebo in the control group.

Primary Outcome Measure Information:

Title

The incidence of abnormal metabolic indexes

Description

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaomin Zhang, M.D.

Phone

+86-13920023990

xiaomzh@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaorong Li, M.D.

Organizational Affiliation

Tianjin Medical University Eye Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Tianjin Medical University Eye Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300000

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

22203527

Citation

Del Barco S, Vazquez-Martin A, Cufi S, Oliveras-Ferraros C, Bosch-Barrera J, Joven J, Martin-Castillo B, Menendez JA. Metformin: multi-faceted protection against cancer. Oncotarget. 2011 Dec;2(12):896-917. doi: 10.18632/oncotarget.387.

Results Reference

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PubMed Identifier

21908880

Citation

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Results Reference

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PubMed Identifier

21953589

Citation

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Results Reference

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PubMed Identifier

12441176

Citation

Schacke H, Docke WD, Asadullah K. Mechanisms involved in the side effects of glucocorticoids. Pharmacol Ther. 2002 Oct;96(1):23-43. doi: 10.1016/s0163-7258(02)00297-8.

Results Reference

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PubMed Identifier

26789102

Citation

Oray M, Abu Samra K, Ebrahimiadib N, Meese H, Foster CS. Long-term side effects of glucocorticoids. Expert Opin Drug Saf. 2016;15(4):457-65. doi: 10.1517/14740338.2016.1140743. Epub 2016 Feb 6.

Results Reference

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PubMed Identifier

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Citation

Gulliford MC, Charlton J, Latinovic R. Risk of diabetes associated with prescribed glucocorticoids in a large population. Diabetes Care. 2006 Dec;29(12):2728-9. doi: 10.2337/dc06-1499. No abstract available.

Results Reference

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PubMed Identifier

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Citation

Perez A, Jansen-Chaparro S, Saigi I, Bernal-Lopez MR, Minambres I, Gomez-Huelgas R. Glucocorticoid-induced hyperglycemia. J Diabetes. 2014 Jan;6(1):9-20. doi: 10.1111/1753-0407.12090. Epub 2013 Oct 29.

Results Reference

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PubMed Identifier

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Citation

Pasieka AM, Rafacho A. Impact of Glucocorticoid Excess on Glucose Tolerance: Clinical and Preclinical Evidence. Metabolites. 2016 Aug 3;6(3):24. doi: 10.3390/metabo6030024.

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Citation

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27416781

Citation

Jeon SM. Regulation and function of AMPK in physiology and diseases. Exp Mol Med. 2016 Jul 15;48(7):e245. doi: 10.1038/emm.2016.81.

Results Reference

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

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