2024-516141-39-00招募中4 期
EFFECT OF ONCE VS TWICE DAILY ADMINISTRATION OF CORTICOSTEROIDS ON BLOOD GLUCOSE IN PATIENTS WITH ANCA-VASCULITIS MEASURED BY CONTINUOUS BLOOD GLUCOSE MONITORING - A PILOT STUDY
Medical University Of Graz1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月18日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean time in target range (70-180mg/dl) measured by blinded continuous glucose measurement (CGM).
研究概览
简要总结
Evaluation of whether splitting the cortisone dose to a twice daily dose leads to increased time in the glucose target range.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Written agreement to participate in the study after detailed explanation of the study
- •Male or female patients
- •New diagnosis of ANCA-associated vasculitis or a relapse of a known ANCA vasculitis
- •Age: ≥18-80 years at the time of biopsy
- •Aprednislon dose of 1mg/kg body weight at the time of inclusion
- •Wants to wear a CGM system for the duration of the study and to receive insulin therapy as needed
排除标准
- •Known diabetes mellitus
- •Women capable of giving birth who are pregnant, breastfeeding, wish to become pregnant or do not use adequate contraception.
- •Skin changes or concomitant circumstances that prevent the placement of a glucose sensor in the examiner's assessment (e.g. scar tissue)
- •Current participation in another clinical trial that would affect study results
- •Relevant acute or chronic disease that, in the investigator's estimation, could affect the patient's safety or affect the study results.
- •Patient's inability to follow study procedures as required
- •Inability of the patient to understand the consent form
结局指标
主要结局
Mean time in target range (70-180mg/dl) measured by blinded continuous glucose measurement (CGM).
Mean time in target range (70-180mg/dl) measured by blinded continuous glucose measurement (CGM).
次要结局
- CRP at initial diagnosis and during course of treatment
- Leukocytes at initial diagnosis and during course of disease
- Number and percent of glucose values (CGM, BG) in the following ranges: 0-<40mg/dl (blood glucose only), 40-<70mg/dl, 70-<100mg/dl, 100-<140mg/dl, 140-<180mg/dl, 180-<300mg/dl, ≥300mg/dl
- Time of glucose values (CGM, BG) in the following ranges: 0-<40mg/dl (blood glucose only), 40-<70mg/dl, 70-<100mg/dl, 100-<140mg/dl, 140-<180mg/dl, 180-<300mg/dl, ≥300mg/dl
- Average daily blood glucose based on preprandial and bedtime glucose values: total and per treatment day
- Mean blood glucose before the respective times: before breakfast, before lunch, before dinner, at bedtime
- Mean blood glucose before start of study during in-patient stay
- Number of insulin injections per day
- Relevant concomitant medication during inpatient stay (corticosteroids, parenteral nutrition, oral antidiabetics)
- Relevant diabetes medication for discharge from inpatient care (insulin therapy - type and dose, oral antidiabetics)
- HbA1c
- Sex
- Age
- Additionally affected organs
- Antibody titer (ANCA, anti-GBM, anti-ds-DNS,..) at initial diagnosis and during course of disease
- Thrombocytes at initial diagnosis and during course of disease
- GFR at initial diagnosis and during course of disease
- Creatinine at initial diagnosis and during course of disease
- Protein and albuminuria at initial diagnosis and during course of disease
- Urinary sediment at initial diagnosis and in the course of the disease
- Therapy after initial diagnosis and during course (e.g. switch to rituximab)
- Birmingham Vasculitis Score (BVAS) on discharge
- Quality of life measured by the SF-36 and KDQOL questionnaire
研究者
Coordination center for Clinical Trials
Scientific
Medical University Of Graz
研究点 (1)
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