Steroid Diabetes in Patients With Kidney Disease

NCT06161701 | Recruiting

• 1 other identifier: KT20220083
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrotic Syndrome

Keywords

steroid diabetes

Outcome Measures

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%

  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

  Time from enrollment to steroid diabetes happens

Study Arms (1)

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

no intervention OTHER

no intervention

Blood glucose management in patients with kidney disease after using glucocorticoids

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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；

You may not qualify if:

• 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。

Sponsors & Collaborators

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

Study Sites (1)

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 0571, China

RECRUITING

MeSH Terms

Conditions

Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Xiaolan Ye, master

  Zhejiang Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaolan Ye, master

CONTACT

+86-0571-85893117; yexl1120@126.com

Ping Huang, doctor

CONTACT

+86-0571-85893117; huangping1841@zjcc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: December 8, 2023
• Study Start: January 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

CN (1)