Nephrotic SyndromeNCT06161701
Steroid Diabetes in Patients With Kidney Disease
An observational study of Nephrotic Syndrome, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
If steroid diabetes is not recognized in time, it will cause irreversible damage to the body. Nephropathy patients are more likely to have steroid diabetes ,the incidence rate up to 25%,due to hypoalbuminemia, high-dose hormone and other reasons, so they need to be closely followed up, identified and intervened in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nephrotic Syndrome
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient or inpatient kidney disease patients seeking treatment at any research hospital
Who may be able to join
- Patients who need to use glucocorticoids due to the following diseases: nephrotic syndrome, Immunoglobulin A nephropathy, membranous nephropathy, Anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV), systemic lupus erythematosus；
- Initial daily dose of glucocorticoids greater than or equal to 10mg of prednisolone；
Who cannot join
- Patients with diabetes；
- Those who are unable to communicate through language；
- Uremic patients；
- Unable to perform blood glucose monitoring and follow-up as required；
- Those who have used glucocorticoids within the past 3 months and have accumulated a dose of 10mg or more of prednisone；
- Participated in other clinical studies。
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, 0571
Xiaolan Ye, master, 86-0571-85893117, yexl1120@126.com
Ping Huang, doctor, 86-0571-85893117, huangping1841@zjcc.org.cn
About this study
Official title: A Study on the Influencing Factors of Glucocorticoid Induced Elevated Blood Glucose in Nephrotic Patients
If steroid diabetes is not recognized in time, it will cause irreversible damage to the body. Nephropathy patients are more likely to have steroid diabetes ,the incidence rate up to 25%,due to hypoalbuminemia, high-dose hormone and other reasons, so they need to be closely followed up, identified and intervened in time.
Read the detailed description
- Patients with nephrosis who had taken glucocorticoid for the first time were followed up, and those who had diabetes themselves were excluded.
- Regularly follow up and record information on glucocorticoid medication, medications that have an impact on blood sugar, fasting blood sugar, 2-hour postprandial blood sugar, and glycated hemoglobin.
- Notify relevant doctors of any cases of elevated blood sugar.
- The total follow-up time is 1 year.
- Conditions
- Nephrotic Syndrome
- Being tested
- no intervention
- Keywords
- steroid diabetes
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Blood glucose management in patients with kidney disease after using glucocorticoids | Blood glucose monitoring for kidney disease patients after taking glucocorticoids Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of steroid diabetes in nephrotic patients after glucocorticoid use
steroid diabetes is defined as the absence of diabetes in the past, which occurs after the use of glucocorticoid:
- Typical symptoms accompanied by any of the following: Fasting blood glucose ≥ 7.0mmol/L or random blood glucose ≥ 11.1mmol/L or plus OGTT 2-hour blood glucose ≥ 11.1mmol/L; Or glycated hemoglobin is greater than or equal to 6.5%;
- If there are no typical symptoms, then it needs to meet any two or more of the above results;
The incidence of steroid diabetes is defined as the number of patients diagnosed with steroid diabetes after glucocorticoid use/the number of patients enrolled * 100%
Measured: If the use of glucocorticoids exceeds one year, observe for one year; If the usage time is less than one year, observe 3 months after discontinuation of medication.
Secondary outcomes (1)
Cumulative use time of glucocorticoid, cumulative dose of glucocorticoid and drugs that may affect blood glucose in combination with steroid diabetes
The cumulative use time of glucocorticoid refers to the time from regular use of glucocorticoid to steroid diabetes;
The cumulative dose of glucocorticoid refers to the cumulative dose of glucocorticoid from the time of regular use of glucocorticoid to the time of occurrence of steroid diabetes, calculated by prednisone;
Medications that may affect blood sugar in combination therapy: Tacrolimus, cyclosporine, hydrochlorothiazide β- Receptor blockers, etc.
Measured: Time from enrollment to steroid diabetes happens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start10 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Wenzhou Medical University, The First People's Hospital of Xiaoshan District, Hangzhou City, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Nanxun District People's Hospital of Huzhou City，China, Wenling Traditional Chinese Medicine Hospital, Affiliated Hospital of Jiaxing University, Taizhou Hospital, The First People's Hospital of Chun'an
- Responsible party
- Sponsor
- Investigators
- Xiaolan Ye, master, Study director, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161701
- Sponsor's protocol ID
- KT20220083
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2023
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: One year after the completion of the study, for researchers who do require relevant data, the basic characteristics of enrolled cases and the development and changes of blood sugar can be provided by email.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Influencing Factors of Glucocorticoid Induced Elevated Blood Glucose in Nephrotic Patients
- ClinicalTrials.gov ID
- NCT06161701
- Acronym / sponsor ID
- KT20220083
- Conditions
- Nephrotic Syndrome
- Keywords
- steroid diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Wenzhou Medical University, The First People's Hospital of Xiaoshan District, Hangzhou City, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Nanxun District People's Hospital of Huzhou City，China, Wenling Traditional Chinese Medicine Hospital, Affiliated Hospital of Jiaxing University, Taizhou Hospital, The First People's Hospital of Chun'an
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 8 Dec 2023 (actual)
- 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.
If steroid diabetes is not recognized in time, it will cause irreversible damage to the body. Nephropathy patients are more likely to have steroid diabetes ,the incidence rate up to 25%,due to hypoalbuminemia, high-dose hormone and other reasons, so they need to be closely followed up, identified and intervened in time.
Detailed description
- Patients with nephrosis who had taken glucocorticoid for the first time were followed up, and those who had diabetes themselves were excluded.
- Regularly follow up and record information on glucocorticoid medication, medications that have an impact on blood sugar, fasting blood sugar, 2-hour postprandial blood sugar, and glycated hemoglobin.
- Notify relevant doctors of any cases of elevated blood sugar.
- The total follow-up time is 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood glucose management in patients with kidney disease after using glucocorticoids | – | Other: no interventionBlood glucose monitoring for kidney disease patients after taking glucocorticoids |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient or inpatient kidney disease patients seeking treatment at any research hospital
Key inclusion criteria (2 listed)
- Patients who need to use glucocorticoids due to the following diseases: nephrotic syndrome, Immunoglobulin A nephropathy, membranous nephropathy, Anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV), systemic lupus erythematosus；
- Initial daily dose of glucocorticoids greater than or equal to 10mg of prednisolone；
Key exclusion criteria (6 listed)
- Patients with diabetes；
- Those who are unable to communicate through language；
- Uremic patients；
- Unable to perform blood glucose monitoring and follow-up as required；
- Those who have used glucocorticoids within the past 3 months and have accumulated a dose of 10mg or more of prednisone；
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 |
|---|---|---|
| no interventionno intervention | Other | Blood glucose management in patients with kidney disease after using glucocorticoids |
Primary outcome
Incidence of steroid diabetes in nephrotic patients after glucocorticoid use
Time frame: If the use of glucocorticoids exceeds one year, observe for one year; If the usage time is less than one year, observe 3 months after discontinuation of medication.
steroid diabetes is defined as the absence of diabetes in the past, which occurs after the use of glucocorticoid: 1. Typical symptoms accompanied by any of the following: Fasting blood glucose ≥ 7.0mmol/L or random blood glucose ≥ 11.1mmol/L or plus OGTT 2-hour blood glucose ≥ 11.1mmol/L; Or glycated hemoglobin is greater than or equal to 6.5%; 2. If there are no typical symptoms, then it needs to meet any two or more of the above results; The incidence of steroid diabetes is defined as the number of patients diagnosed with steroid diabetes after glucocorticoid use/the number of patients enrolled * 100%
1 secondary outcome
Cumulative use time of glucocorticoid, cumulative dose of glucocorticoid and drugs that may affect blood glucose in combination with steroid diabetes
Time frame: Time from enrollment to steroid diabetes happens
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: Undecided. One year after the completion of the study, for researchers who do require relevant data, the basic characteristics of enrolled cases and the development and changes of blood sugar can be provided by email.
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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.
Xiaolan Ye, master study director
Zhejiang Provincial People's 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 Nephrotic Syndrome, run by Zhejiang Provincial People's 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Apr 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolan Ye, master (+86-0571-85893117, yexl1120@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of steroid diabetes in nephrotic patients after glucocorticoid use (time frame: If the use of glucocorticoids exceeds one year, observe for one year; If the usage time is less than one year, observe 3 months after discontinuation of medication.). 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 29 Apr 2024.