Clinical trial NCT02824757: The Effects of Glucocorticoids on Glucose Metabolism in Patients With Interstitial Lung Disease
Official title: Explore the Effects of Glucocorticoids on Glucose Metabolism by Continuous Glucose Monitoring in Patients With Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Keywords: interstitial lung disease
glucocorticcoid
glucose
continuous glucose monitor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Interstitial lung diseases(ILD), also known as diffuse parenchymal lung diseases, are a group of lung diseases with similar clinical, radiological and pathological manifestation. The causes include connective tissue disease-associated interstitial lung diseases, idiopathic interstitial pneumonias, granulomatous lung disorders etc. Most patients with ILD are recommended to take the glucocorticoid treatment. The adverse effects of glucocorticoids include the glucose metabolism disorder, weight gain, high blood pressure and osteoporosis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The interstitial glucose values measured by CGMS (continuous glucose measure service)
timeFrame: 3 months
Secondary outcomes:
measure: fasting insulin
timeFrame: 3 months
measure: fasting glucose
timeFrame: 3 months
measure: fasting C peptide
timeFrame: 3 months
measure: HbA1c
timeFrame: 3 months
measure: Glycated albumin
timeFrame: 3 months
Other outcomes:
measure: Weight
timeFrame: 3 months
measure: waistline
timeFrame: 3 months
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Endocrinology department, Peking Union Medical College Hospital
name: Weigang Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: