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RecruitingNCT06161701Updated Apr 29, 2024

Steroid Diabetes in Patients With Kidney Disease

An observational study in Nephrotic Syndrome, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-29.

Sponsored by Zhejiang Provincial People's Hospital · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 34 studies in Nephrotic Syndrome with a site in China — 19 open to participants now, 21 under way, 5 of them phase 3. Nephrotic Syndrome · China.

Started
2024
with 2 others
Observational
9 of 34
4 open now
Primary completion
2026-12
later than 11 of 20 live
Registered
18th of 34
by date

Among the 34 studies in Nephrotic Syndrome with a site in China, this one is one of 3 that started in 2024, is one of 9 observational ones, reaches primary completion later than 11 of the 20 other live ones, and was the 18th registered.

By phase

34 studies; the count open now beside each. This study's row is marked.

Phase 310 · 5 open
Observationalthis study9 · 4 open
Phase 17 · 7 open
Phase 24 · 2 open
Phase 43 · 1 open
No phase1 · 0 open

By the year they started

First in 2011; this study’s year is marked. 3 started in 2024.

Size and results

Median enrollment 36 across the 25 interventional studies, 300 across the 9 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 34 studies in Nephrotic Syndrome with a site in China, or all of them as a file.
02

Study 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 time.

Read the detailed description
  1. Patients with nephrosis who had taken glucocorticoid for the first time were followed up, and those who had diabetes themselves were excluded.
  2. 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.
  3. Notify relevant doctors of any cases of elevated blood sugar.
  4. The total follow-up time is 1 year.
03

Conditions studied

  • Nephrotic Syndrome

Browse trials for

Keywords

  • steroid diabetes
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatient or inpatient kidney disease patients seeking treatment at any research hospital

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who need to use due to the following diseases: nephrotic syndrome, Immunoglobulin A nephropathy, membranous nephropathy, Anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV), systemic lupus erythematosus;
  2. Initial daily dose of glucocorticoids greater than or equal to 10mg of prednisolone;

Exclusion criteria

Exclusion Criteria:

  1. Patients with diabetes;
  2. Those who are unable to communicate through language;
  3. Uremic patients;
  4. Unable to perform blood glucose monitoring and follow-up as required;
  5. Those who have used within the past 3 months and have accumulated a dose of 10mg or more of prednisone;
  6. Participated in other clinical studies。
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Blood glucose management in patients with kidney disease after using glucocorticoids

    Blood glucose monitoring for kidney disease patients after taking glucocorticoids

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. 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: 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%

    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.

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.

    Time frame: Time from enrollment to steroid diabetes happens

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2023
First posted
Dec 8, 2023
StartActual
Jan 10, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Feb 28, 2027
Last update
Apr 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06161701
Lead sponsor
Zhejiang Provincial People's Hospital
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
First posted
Dec 8, 2023
Start date
Jan 10, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Apr 29, 2024

Study contacts

Xiaolan Ye, master
Contact
yexl1120@126.com
+86-0571-85893117
Ping Huang, doctor
Contact
huangping1841@zjcc.org.cn
+86-0571-85893117
Xiaolan Ye, master
study director · Zhejiang Provincial People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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