Glucocorticoid-induced HyperglycemiaCGMNCT03018600
Continuous Glucose Monitoring on Patients With Active Autoimmune Diseases Following High-dose Predisone Treatment
An observational study of Glucocorticoid-induced Hyperglycemia, run by Peking Union Medical College Hospital.
Trial summary
Glucocorticoid is widely used in clinical treatment. Recently, there was research about glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active autoimmune diseases. Read more about this study
- Who is it for?
- Ages 25 to 46 years
- Conditions the study is for
- Glucocorticoid-induced Hyperglycemia
- What is being tested?
- diet and exercise intervention
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Sep 2016
- 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 25 to 46 years
- All sexes
- No healthy volunteers
- Adult
Study population: The subjects were recruited from inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016. Patients' primary disease was diagnosed according to the criteria by American College of Rheumatology. The spectrum of autoimmune disease included Systemic lupus Erythematosus (SLE), Connective tissue disorders, Sjogren Syndrome, Systemic sclerosis, IgG4-related disease, Bahcet's disease, ANCA-associated vasculitis, polymyositis, dermatomyositis.
Who may be able to join
- Young patients with exacerbation of autoimmune disease, requiring 1-2mg/kg/day prednisone or equivalent for treatment;
- could undergo <15mg/kg/day prednisone or equivalent glucocorticoid maintenance in the previous three months;
Who cannot join
- patients with history of diabetes;
- patients with severe organ dysfunction or failure;
- patients with febrile conditions;
About this study
Official title: Glucose Profiles of High-Dose Glucocorticoid Treatment in Young Patients With Diverse Autoimmune Disease With or Without Long-Term Low-Dose Glucocorticoid
Glucocorticoid is widely used in clinical treatment. Recently, there was research about glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active autoimmune diseases. Through this prospective trial, the investigators wanted to know the blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or equivalent) in young patients (30-40 years) with active autoimmune diseases with or without low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for 72 hours to get a better understanding of the glucose levels.
Read the detailed description
As known to all, the dosage and duration of glucocorticoid influences the glucose levels in different diseases. Continuous glucose monitoring becomes a newly effective technology to better understand the glucose level. In this study,the investigators enrolled 25 patients with certain active autoimmune diseases during high-dosage glucocorticoid therapy at Peking Union Medical College Hospital. It was done by monitoring three-day continuous glucose levels by holding continuous glucose monitoring system underneath the skin, which helped to show a unique picture of fluctuations. The participants were divided into two groups according to the glucocorticoid therapy. Group 1 enrolled subjects who were newly commenced 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for at least five days. Group 2 enrolled subjects who had underwent less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months but treated with high-dose glucocorticoid for the relapse during the study This finding is useful for the suitable treatment to control the hyperglycemia in young patients.
- Conditions
- Glucocorticoid-induced Hyperglycemia
- Being tested
- diet and exercise intervention
- Keywords
- prednisone, autoimmune disease
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and exercise interventionBehavioural
consult nutrious doctors giving specific food and take regular exercise when under steroid therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | We included 15 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) to the patients every morning at 8am for at least five days. Receives: Behavioral: diet and exercise intervention | |
| 2 | We included 10 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: using less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months and now treating with 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for the relapse of primary autoimmune disease for at least five days. Receives: Behavioral: diet and exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
glucose values of 24 hours (mmol/L);
Measured: 72 hours CGMS monitoring
Secondary outcomes (1)
the amounts of patients developing hyperglycemia
Measured: 72 hours CGMS monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoid-induced HyperglycemiaStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018600
- Sponsor's protocol ID
- PekingUMCH-ZS965
- Acronym
- CGM
- Status last verified
- Apr 2016
- First submitted
- 7 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Profiles of High-Dose Glucocorticoid Treatment in Young Patients With Diverse Autoimmune Disease With or Without Long-Term Low-Dose Glucocorticoid
- ClinicalTrials.gov ID
- NCT03018600
- Acronym / sponsor ID
- CGM / PekingUMCH-ZS965
- Conditions
- Glucocorticoid-induced Hyperglycemia
- Keywords
- prednisone, autoimmune disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Jan 2017 (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.
Glucocorticoid is widely used in clinical treatment. Recently, there was research about glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active autoimmune diseases. Through this prospective trial, the investigators wanted to know the blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or equivalent) in young patients (30-40 years) with active autoimmune diseases with or without low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for 72 hours to get a better understanding of the glucose levels.
Detailed description
As known to all, the dosage and duration of glucocorticoid influences the glucose levels in different diseases. Continuous glucose monitoring becomes a newly effective technology to better understand the glucose level. In this study,the investigators enrolled 25 patients with certain active autoimmune diseases during high-dosage glucocorticoid therapy at Peking Union Medical College Hospital. It was done by monitoring three-day continuous glucose levels by holding continuous glucose monitoring system underneath the skin, which helped to show a unique picture of fluctuations. The participants were divided into two groups according to the glucocorticoid therapy. Group 1 enrolled subjects who were newly commenced 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for at least five days. Group 2 enrolled subjects who had underwent less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months but treated with high-dose glucocorticoid for the relapse during the study This finding is useful for the suitable treatment to control the hyperglycemia in young patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: diet and exercise interventionWe included 15 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) to the patients every morning at 8am for at least five days. |
| 2 | – | Behavioral: diet and exercise interventionWe included 10 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: using less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months and now treating with 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for the relapse of primary autoimmune disease for at least five days. |
Who may qualify
- Ages
- 25 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The subjects were recruited from inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016. Patients' primary disease was diagnosed according to the criteria by American College of Rheumatology. The spectrum of autoimmune disease included Systemic lupus Erythematosus (SLE), Connective tissue disorders, Sjogren Syndrome, Systemic sclerosis, IgG4-related disease, Bahcet's disease, ANCA-associated vasculitis, polymyositis, dermatomyositis.
Key inclusion criteria (2 listed)
- Young patients with exacerbation of autoimmune disease, requiring 1-2mg/kg/day prednisone or equivalent for treatment;
- could undergo <15mg/kg/day prednisone or equivalent glucocorticoid maintenance in the previous three months;
Key exclusion criteria (3 listed)
- patients with history of diabetes;
- patients with severe organ dysfunction or failure;
- patients with febrile conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet and exercise interventionconsult nutrious doctors giving specific food and take regular exercise when under steroid therapy | Behavioural | 1, 2 |
Primary outcome
glucose values of 24 hours (mmol/L);
Time frame: 72 hours CGMS monitoring
1 secondary outcome
the amounts of patients developing hyperglycemia
Time frame: 72 hours CGMS monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glucocorticoid-induced Hyperglycemia, run by Peking Union Medical College Hospital.
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 2 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: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glucose values of 24 hours (mmol/L); (time frame: 72 hours CGMS monitoring). 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 12 Jan 2017.