Steroid Diabetes in Patients With Kidney Disease

Nephrotic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161701
• Other study ID #: KT20220083
• Status: Recruiting
• Start date: January 10, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: April 2024
• Source: Zhejiang Provincial People's Hospital
• Contact: Xiaolan Ye, master
• Phone: +86-0571-85893117
• Email: yexl1120[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 28, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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?

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Zhejiang provincial people's hospital	Hangzhou	Zhejiang

Sponsors (9)

Lead Sponsor

Collaborator

Zhejiang Provincial People's Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 ß- Receptor blockers, etc.	Time from enrollment to steroid diabetes happens