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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Glucocorticoid-induced Hyperglycemia

Intervention / Treatment
-----------------
* Behavioral: diet and exercise intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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;

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 46 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>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<br>* consult nutrious doctors giving specific food and take regular exercise when under steroid therapy<br>|
| 2<br>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<br>* consult nutrious doctors giving specific food and take regular exercise when under steroid therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prednisone, autoimmune disease