Steroid Diabetes in Patients With Kidney Disease
ConditionNephrotic Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhejiang Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
Patients with diabetes；
Those who are unable to communicate through language；
Uremic patients；
Unable to perform blood glucose monitoring and follow-up as required；
Trial population
Outpatient or inpatient kidney disease patients seeking treatment at any research hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
no intervention
Other interventionno intervention
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Blood glucose management in patients with kidney disease after using glucocorticoids1 intervention
Trial outcomes
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%
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.Secondary outcomes
1
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 frame
Time from enrollment to steroid diabetes happensSponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhejiang Provincial People's Hospital
Lead sponsor
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
Source ClinicalTrials.gov