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

NCT03525028 | Unknown

• 1 other identifier: 2017KY-06
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis; Metformin; Glucocorticoid

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Study Arms (2)

Metformin group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Metformin DRUG

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.

Metformin group

Placebo DRUG

The investigators use placebo in the control group.

Placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Tianjin Medical University Eye Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 22203527 BACKGROUND

• Hoes JN, van der Goes MC, van Raalte DH, van der Zijl NJ, den Uyl D, Lems WF, Lafeber FP, Jacobs JW, Welsing PM, Diamant M, Bijlsma JW. Glucose tolerance, insulin sensitivity and beta-cell function in patients with rheumatoid arthritis treated with or without low-to-medium dose glucocorticoids. Ann Rheum Dis. 2011 Nov;70(11):1887-94. doi: 10.1136/ard.2011.151464. Epub 2011 Sep 10.

  PMID: 21908880 RESULT

• den Uyl D, van Raalte DH, Nurmohamed MT, Lems WF, Bijlsma JW, Hoes JN, Dijkmans BA, Diamant M. Metabolic effects of high-dose prednisolone treatment in early rheumatoid arthritis: balance between diabetogenic effects and inflammation reduction. Arthritis Rheum. 2012 Mar;64(3):639-46. doi: 10.1002/art.33378.

  PMID: 21953589 RESULT

• 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.

  PMID: 12441176 RESULT

• 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.

  PMID: 26789102 RESULT

• 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.

  PMID: 17130214 RESULT

• 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.

  PMID: 24103089 RESULT

• 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.

  PMID: 27527232 RESULT

• Kahn BB, Alquier T, Carling D, Hardie DG. AMP-activated protein kinase: ancient energy gauge provides clues to modern understanding of metabolism. Cell Metab. 2005 Jan;1(1):15-25. doi: 10.1016/j.cmet.2004.12.003.

  PMID: 16054041 RESULT

• 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.

  PMID: 27416781 RESULT

MeSH Terms

Conditions

Uveitis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Xiaorong Li, M.D.

  Tianjin Medical University Eye Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaomin Zhang, M.D.

CONTACT

+86-13920023990; xiaomzh@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Tianjin Medical University Eye Institute，archiater

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: May 15, 2018
• Study Start: November 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will become available starting 6 months after publication.
• Access Criteria: The study protocol,statistical analysis plan,informed consent form and clinical study report are to be shared with other researchers.

Locations

CN (1)