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NCT Number: NCT06161701

Steroid Diabetes in Patients With Kidney Disease

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.

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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；

Exclusion criteria

  • 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。

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. 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:

    • 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%

Secondary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ping Huang, doctor

CONTACT

[email protected]

+86-0571-85893117

Xiaolan Ye, master

CONTACT

[email protected]

+86-0571-85893117

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 8, 2023
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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