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Completed

NCT Number: NCT03018600

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

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.

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Key information

Age range

25 year–46 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

diet and exercise intervention

Behavioral

consult nutrious doctors giving specific food and take regular exercise when under steroid therapy

Primary outcomes

  1. glucose values of 24 hours (mmol/L);

    Time frame: 72 hours CGMS monitoring

Secondary outcomes

  1. the amounts of patients developing hyperglycemia

    Time frame: 72 hours CGMS monitoring

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Acronym: CGM

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 12, 2017
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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