The Effects of Glucocorticoids on Glucose Metabolism in Patients With Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

Official title:

Explore the Effects of Glucocorticoids on Glucose Metabolism by Continuous Glucose Monitoring in Patients With Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824757
• Other study ID #: Zhao-ZS965
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2016
• Last updated: July 7, 2016
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: July 2016
• Source: Peking Union Medical College Hospital
• Contact: Jiapei Li, MD
• Phone: +8618510685269
• Email: nemoljp[@]sina.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial Summary

This study is aimed at exploring the effects of glucocorticoids on glucose metabolism in patients with interstitial lung disease. Patients with interstitial lung disease who is on the medication of 15mg prednisolone and 7.5mg prednisolone conduct the continuous glucose monitoring (CGM). The data attained from the CGM are used to define the glycemic characteristics in patients using glucocorticoids and the difference of glucose features due to different doses.

Description:

Patients diagnosed of interstitial lung disease and treating with glucocorticoids could be enrolled in this clinical trial. Those who is in an acute inflammatory phase and diagnosed with hemorrhagic disease should are excluded, so are those unwilling to carry the continuous glucose monitoring (CGM) device. When the dose of prednisolone is applied 15mg per day steadily and is going to be decreased, the CGM is conducted. At the same time, blood tests evaluating the glucose metabolism are measured, including HbA1c, GA, fasting insulin and fasting glucose. After taking 7.5mg prednisolone per day for 3 months, participants do the CGM and blood tests again to evaluate the glucose metabolism during this period. The CGM data could be used for the glucose evaluation, which can manifest the glucose characteristics in the circumstances of glucocorticoid use. By comparing the CGM data and the blood tests, the investigators hope to find the different features of the glucose metabolism due to different doses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with interstitial lung disease

Exclusion Criteria:

• Patients who are in an acute inflammatory phase

• Patients who are diagnosed hemorrhagic disease

• Patients who are unwilling to carry the continuous glucose monitoring device

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	The weight of each participant will be recorded to evaluate the weight change during the study.	3 months	Yes
Other	waistline	The waistline of each participant will be recorded to evaluate the weight change during the study.	3 months	Yes
Primary	The interstitial glucose values measured by CGMS (continuous glucose measure service)	A group of interstitial glucose values will be attained by the CGMS, the number of which count up to more than 1000. These data will undergo statistical process. CGM will be conducted twice when the participants take 15mg prednisolone stably and take 7.5mg prednisolone for 3 months. The difference between the two group of data will be evaluated and discussed.	3 months	Yes
Secondary	fasting insulin	The fasting insulin can evaluate the function of pancreatic beta cell to some extent. The fasting insulin will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.	3 months	Yes
Secondary	fasting glucose	The fasting glucose could evaluate the glucose metabolism to some extent. The fasting glucose will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.	3 months	Yes
Secondary	fasting C peptide	The fasting C peptide could evaluate the function of pancreatic beta cell to some extent. The fasting C peptide will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.	3 months	Yes
Secondary	HbA1c	HbA1c could reflect the average blood glucose for 3 months. The HbA1c will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.	3 months	Yes
Secondary	Glycated albumin	The glycated albumin could evaluate the average blood glucose in the previous 2 weeks to 1 month. The glycated albumin will be evaluated twice when the participants take 15mg prednisolone stably and when the participants take 7.5mg prednisolone for 3 months.	3 months	Yes