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

NCT02824757 | Unknown DMC

• 1 other identifier: Zhao-ZS965
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Keywords

interstitial lung disease; glucocorticcoid; glucose; continuous glucose monitor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• fasting insulin

  3 months

• fasting glucose

  3 months

• fasting C peptide

  3 months

• HbA1c

  3 months

• Glycated albumin

  3 months

Other Outcomes (2)

• Weight

  3 months

• waistline

  3 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients diagnosed with interstitial lung disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Weigang Zhao, MD

  Endocrinology department, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiapei Li, MD

CONTACT

+8618510685269; nemoljp@sina.cn

Weigang Zhao, MD

CONTACT

+8613910054636; xiehezhaoweigang@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: July 7, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 11, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)