Continuous Glucose Monitoring on Patients With Active Autoimmune Diseases Following High-dose Predisone Treatment (CGM)

Glucose Profiles of High-Dose Glucocorticoid Treatment in Young Patients With Diverse Autoimmune Disease With or Without Long-Term Low-Dose Glucocorticoid

Glucocorticoid is widely used in clinical treatment. Recently, there was research about glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active autoimmune diseases. Through this prospective trial, the investigators wanted to know the blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or equivalent) in young patients (30-40 years) with active autoimmune diseases with or without low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for 72 hours to get a better understanding of the glucose levels.

Study Overview

• Status: Completed
• Conditions: Glucocorticoid-induced Hyperglycemia
• Intervention / Treatment: Behavioral: diet and exercise intervention

Detailed Description

As known to all, the dosage and duration of glucocorticoid influences the glucose levels in different diseases. Continuous glucose monitoring becomes a newly effective technology to better understand the glucose level. In this study,the investigators enrolled 25 patients with certain active autoimmune diseases during high-dosage glucocorticoid therapy at Peking Union Medical College Hospital. It was done by monitoring three-day continuous glucose levels by holding continuous glucose monitoring system underneath the skin, which helped to show a unique picture of fluctuations. The participants were divided into two groups according to the glucocorticoid therapy. Group 1 enrolled subjects who were newly commenced 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for at least five days. Group 2 enrolled subjects who had underwent less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months but treated with high-dose glucocorticoid for the relapse during the study This finding is useful for the suitable treatment to control the hyperglycemia in young patients.

• Study Type: Observational
• Enrollment (Actual): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The subjects were recruited from inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016. Patients' primary disease was diagnosed according to the criteria by American College of Rheumatology. The spectrum of autoimmune disease included Systemic lupus Erythematosus (SLE), Connective tissue disorders, Sjogren Syndrome, Systemic sclerosis, IgG4-related disease, Bahcet's disease, ANCA-associated vasculitis, polymyositis, dermatomyositis.

Description

Inclusion Criteria:

• Young patients with exacerbation of autoimmune disease, requiring 1-2mg/kg/day prednisone or equivalent for treatment;
• could undergo <15mg/kg/day prednisone or equivalent glucocorticoid maintenance in the previous three months;

Exclusion Criteria:

• patients with history of diabetes;
• patients with severe organ dysfunction or failure;
• patients with febrile conditions;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; We included 15 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) to the patients every morning at 8am for at least five days.	Behavioral: diet and exercise intervention; consult nutrious doctors giving specific food and take regular exercise when under steroid therapy
2; We included 10 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: using less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months and now treating with 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for the relapse of primary autoimmune disease for at least five days.	Behavioral: diet and exercise intervention; consult nutrious doctors giving specific food and take regular exercise when under steroid therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
glucose values of 24 hours (mmol/L);	72 hours CGMS monitoring

Secondary Outcome Measures

Outcome Measure	Time Frame
the amounts of patients developing hyperglycemia	72 hours CGMS monitoring

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 7, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Estimate): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: prednisone, autoimmune disease
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Hyperglycemia; Autoimmune Diseases
• Other Study ID Numbers: PekingUMCH-ZS965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO