A Clinical Trial of Metformin to Decrease Glucocorticoids Side Effects in Patients With Autoimmune Uveitis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03525028 |
|
Recruitment Status :
Recruiting
First Posted : May 15, 2018
Last Update Posted : September 11, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Uveitis Metformin Glucocorticoid | Drug: Metformin Drug: Placebo | Not Applicable |
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 (Clinical Trial) |
| Estimated 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 : | November 1, 2018 |
| Estimated Primary Completion Date : | January 1, 2023 |
| Estimated Study Completion Date : | January 1, 2023 |
| 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. |
- 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≥5.2 mmol/L (200 mg/d1), TG≥1.7 mmol/L (150 mg/dl) or BMI increased 1 kg/m^2 than before in the process of follow-up twice in a row.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 <5.2 mmol/L(200 mg／d1) and TG <1.7 mmol/L(150 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525028
| Contact: Xiaomin Zhang, M.D. | +86-13920023990 | xiaomzh@126.com |
| China, Tianjin | |
| Tianjin Medical University Eye Hospital | Recruiting |
| Tianjin, Tianjin, China, 300000 | |
| Study Director: | Xiaorong Li, M.D. | Tianjin Medical University Eye Hospital |
Other 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 Key Record Dates |
| Last Update Posted: | September 11, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | The study protocol,statistical analysis plan,informed consent form and clinical study report are to be shared with other researchers. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Uveitis Uveal Diseases Eye Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs |