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临床试验/NCT06161701
NCT06161701招募中不适用

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

Zhejiang Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Incidence of steroid diabetes in nephrotic patients after glucocorticoid use

研究概览

简要总结

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.

详细描述

  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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

  • 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。

结局指标

主要结局

Incidence of steroid diabetes in nephrotic patients after glucocorticoid use

时间窗: 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.

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%

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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