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

Glucocorticoid-induced Hyperglycemia Clinical Trial

— CGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018600
• Other study ID #: PekingUMCH-ZS965
• Status: Completed
• Phase: N/A
• First received: January 7, 2017
• Last updated: January 10, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 46 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autoimmune Diseases
• Glucocorticoid-induced Hyperglycemia
• Hyperglycemia

Intervention

Behavioral:
• diet and exercise intervention
consult nutrious doctors giving specific food and take regular exercise when under steroid therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose values of 24 hours (mmol/L);		72 hours CGMS monitoring	No
Secondary	the amounts of patients developing hyperglycemia		72 hours CGMS monitoring	No