Clinical trial NCT06161701: Steroid Diabetes in Patients With Kidney Disease
Official title: A Study on the Influencing Factors of Glucocorticoid Induced Elevated Blood Glucose in Nephrotic Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nephrotic Syndrome
Keywords: steroid diabetes
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: The Third Affiliated Hospital of Wenzhou Medical University
name: The First People's Hospital of Xiaoshan District, Hangzhou City
name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: Nanxun District People's Hospital of Huzhou City，China
name: Wenling Traditional Chinese Medicine Hospital
name: Affiliated Hospital of Jiaxing University
name: Taizhou Hospital
name: The First People's Hospital of Chun'an
First posted: 2023-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient or inpatient kidney disease patients seeking treatment at any research hospital

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.

Eligibility criteria: 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。

Primary outcomes:
measure: Incidence of steroid diabetes in nephrotic patients after glucocorticoid use
timeFrame: 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:
measure: Cumulative use time of glucocorticoid, cumulative dose of glucocorticoid and drugs that may affect blood glucose in combination with steroid diabetes
timeFrame: Time from enrollment to steroid diabetes happens
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang provincial people's hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Provincial People's Hospital
name: Xiaolan Ye, master
role: STUDY_DIRECTOR
References: