Interstitial Lung DiseaseNCT02824757
The Effects of Glucocorticoids on Glucose Metabolism in Patients With Interstitial Lung Disease
An observational study of Interstitial Lung Disease, run by Peking Union Medical College Hospital at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with interstitial lung disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Weigang Zhao, MD, 13910054636, xiehezhaoweigang@163.com
About this study
Official title: Explore the Effects of Glucocorticoids on Glucose Metabolism by Continuous Glucose Monitoring in Patients With Interstitial Lung Disease
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.
Read the 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.
- Conditions
- Interstitial Lung Disease
- Keywords
- interstitial lung disease, glucocorticcoid, glucose, continuous glucose monitor
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weigang Zhao, MD, Principal investigator, Endocrinology department, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824757
- Sponsor's protocol ID
- Zhao-ZS965
- Status last verified
- Jul 2016
- First submitted
- 15 May 2016
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Effects of Glucocorticoids on Glucose Metabolism by Continuous Glucose Monitoring in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02824757
- Acronym / sponsor ID
- Zhao-ZS965
- Conditions
- Interstitial Lung Disease
- Keywords
- interstitial lung disease, glucocorticcoid, glucose, continuous glucose monitor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with interstitial lung disease
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
fasting insulin
Time frame: 3 months
fasting glucose
Time frame: 3 months
fasting C peptide
Time frame: 3 months
HbA1c
Time frame: 3 months
Glycated albumin
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weigang Zhao, MD principal investigator
Endocrinology department, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiapei Li, MD (+8618510685269, nemoljp@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The interstitial glucose values measured by CGMS (continuous glucose measure service) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.