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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02824757
Enrollment
40
Registered
2016-07-07
Start date
2016-03-31
Completion date
2017-03-31
Last updated
2016-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Keywords

interstitial lung disease, glucocorticcoid, glucose, continuous glucose monitor

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The interstitial glucose values measured by CGMS (continuous glucose measure service)3 monthsA 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.

Secondary

MeasureTime frameDescription
fasting glucose3 monthsThe 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.
fasting C peptide3 monthsThe 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.
HbA1c3 monthsHbA1c 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.
fasting insulin3 monthsThe 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.
Glycated albumin3 monthsThe 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.

Other

MeasureTime frameDescription
waistline3 monthsThe waistline of each participant will be recorded to evaluate the weight change during the study.
Weight3 monthsThe weight of each participant will be recorded to evaluate the weight change during the study.

Countries

China

Contacts

Primary ContactJiapei Li, MD
nemoljp@sina.cn+8618510685269
Backup ContactWeigang Zhao, MD
xiehezhaoweigang@163.com+8613910054636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026