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Steroid Diabetes in Patients With Kidney Disease

A Study on the Influencing Factors of Glucocorticoid Induced Elevated Blood Glucose in Nephrotic Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06161701
Enrollment
300
Registered
2023-12-08
Start date
2024-01-10
Completion date
2027-02-28
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotic Syndrome

Keywords

steroid diabetes

Brief 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.

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.

Interventions

OTHERno intervention

no intervention

Sponsors

The Third Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER
The First People's Hospital of Xiaoshan District, Hangzhou City
CollaboratorUNKNOWN
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
CollaboratorOTHER
Nanxun District People's Hospital of Huzhou City,China
CollaboratorUNKNOWN
Wenling Traditional Chinese Medicine Hospital
CollaboratorUNKNOWN
Affiliated Hospital of Jiaxing University
CollaboratorOTHER
Taizhou Hospital
CollaboratorOTHER
The First People's Hospital of Chun'an
CollaboratorUNKNOWN
Zhejiang Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. 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; 2. Initial daily dose of glucocorticoids greater than or equal to 10mg of prednisolone;

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 glucocorticoids within the past 3 months and have accumulated a dose of 10mg or more of prednisone; 6. Participated in other clinical studies。

Design outcomes

Primary

MeasureTime frameDescription
Incidence of steroid diabetes in nephrotic patients after glucocorticoid useIf 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%

Secondary

MeasureTime frameDescription
Cumulative use time of glucocorticoid, cumulative dose of glucocorticoid and drugs that may affect blood glucose in combination with steroid diabetesTime from enrollment to steroid diabetes happensThe 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.

Countries

China

Contacts

Primary ContactXiaolan Ye, master
yexl1120@126.com+86-0571-85893117
Backup ContactPing Huang, doctor
huangping1841@zjcc.org.cn+86-0571-85893117

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026