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

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ClinicalTrials.gov Identifier: NCT02824757
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
gwcmc

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.

Condition or disease
Interstitial Lung Disease

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.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Explore the Effects of Glucocorticoids on Glucose Metabolism by Continuous Glucose Monitoring in Patients With Interstitial Lung Disease
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort
known diabetes
Participants have been diagnosed diabetes.
known prediabetes
Participants have been diagnosed impaired glucose tolerance or impaired fasting glucose before.
normal glucose tolerance
Participants have done the oral glucose tolerance test and been confirmed the normal glucose tolerance.
unclear glucose tolerance condition
Participants who have not done oral glucose tolerance test or been diagnosed diabetes before.



Primary Outcome Measures :
  1. The interstitial glucose values measured by CGMS (continuous glucose measure service) [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. fasting insulin [ Time Frame: 3 months ]
    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.

  2. fasting glucose [ Time Frame: 3 months ]
    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. fasting C peptide [ Time Frame: 3 months ]
    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.

  4. HbA1c [ Time Frame: 3 months ]
    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.

  5. Glycated albumin [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Weight [ Time Frame: 3 months ]
    The weight of each participant will be recorded to evaluate the weight change during the study.

  2. waistline [ Time Frame: 3 months ]
    The waistline of each participant will be recorded to evaluate the weight change during the study.


Biospecimen Retention:   Samples Without DNA
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824757


Contacts
Contact: Jiapei Li, MD +8618510685269 nemoljp@sina.cn
Contact: Weigang Zhao, MD +8613910054636 xiehezhaoweigang@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Weigang Zhao, MD    13910054636    xiehezhaoweigang@163.com   
Sponsors and Collaborators
gwcmc
Investigators
Principal Investigator: Weigang Zhao, MD Endocrinology department, Peking Union Medical College Hospital

Responsible Party: gwcmc
ClinicalTrials.gov Identifier: NCT02824757     History of Changes
Other Study ID Numbers: Zhao-ZS965
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by gwcmc:
interstitial lung disease
glucocorticcoid
glucose
continuous glucose monitor

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs