Steroid Diabetes in Patients With Kidney Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Nephrotic Syndrome
• Intervention / Treatment: Other: no intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Xiaolan Ye, Master; Phone Number: +86-0571-85893117; Email: yexl1120@126.com
• Study Contact Backup: Name: Ping Huang, doctor; Phone Number: +86-0571-85893117; Email: huangping1841@zjcc.org.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 0571
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Xiaolan Ye, master; Phone Number: 86-0571-85893117; Email: yexl1120@126.com
      • Contact: Ping Huang, doctor; Phone Number: 86-0571-85893117; Email: huangping1841@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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。

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Blood glucose management in patients with kidney disease after using glucocorticoids; Blood glucose monitoring for kidney disease patients after taking glucocorticoids	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 from enrollment to steroid diabetes happens

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Collaborators: Taizhou Hospital; The Fourth Affiliated Hospital of Zhejiang University School of Medicine; The Third Affiliated Hospital of Wenzhou Medical University; Wenling Traditional Chinese Medicine Hospital; Affiliated Hospital of Jiaxing University; The First People's Hospital of Xiaoshan District, Hangzhou City; Nanxun District People's Hospital of Huzhou City，China; The First People's Hospital of Chun'an
• Investigators: Study Director: Xiaolan Ye, master, Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: steroid diabetes
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: KT20220083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No