EUCTR2008-005708-18-GB进行中（未招募）1 期
Prevention of metabolic complications of glucocorticoid excess - Prevention of metabolic complications of glucocorticoid excess
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion Criteria for patients to be included in the Prevention” arm
- •·Patients diagnosed with a rheumatological disease and not started yet on GC treatment
- •·minimal duration of prospective therapy 12w
- •·dose of prednisolone =10mg/d (or equivalent GC)
- •·ambulatory patients
- •·patients >18 years and ·ability to understand verbal and written instructions and informed consent
- •Inclusion Criteria for patients to be included in the Treatment” arm
- •·Patients treated with GC >20mg/d for at least 4wks
- •·minimal duration of prospective therapy 12w
- •·dose of prednisolone =10mg/d (or equivalent GC)
- •·ambulatory patients
- •·patients >18 years old
- •·ability to understand verbal and written instructions and informed consent
- •Inclusion Criteria for patients diagnosed with Cushing’s syndrome
- •·Patients diagnosed with Cushing’s syndrome
- •·ambulatory patients
- •·patients >18 years old
- •·ability to understand verbal and written instructions and informed consent
- •Exclusion Criteria
- •·Prior therapy with metformin during the last 6 months
- •·pre-existing diabetes
- •·liver impairment: ALT and/or AST =2.5 x upper normal limit
- •·renal impairment: serum creatinine levels =135.0 µmol/L in males and =110.0 µmol/L in females
- •·current malignancy
- •·patients unable to give written informed consent
- •·or patients not understanding English and no translation available
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Prior therapy with metformin during the last 6 months
- •·pre-existing diabetes
- •·liver impairment: ALT and/or AST =2.5 x UNL
- •·renal impairment: serum creatinine levels =135.0 µmol/L in males and =110.0 µmol/L in females
- •·current malignancy
- •·patients unable to give written informed consent
- •·or patients not understanding English and no translation available
研究者
相似试验
已完成
4 期
Drug therapy for the prevention of glucocorticoid induced osteoporosis in elderly patients: teriparatide or bisphosphonates?glucocorticoid-induced osteoporosisJPRN-UMIN000009222Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity40
进行中（未招募）
不适用
Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritisPatients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher.Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use.MedDRA version: 12.0Level: LLTClassification code 10060732Term: Rheumatoid arthritis flare upEUCTR2009-017051-10-NLMC Utrecht
撤回
不适用
Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritisrheumatoid arthritisrheumatic disease100184241000381610023213NL-OMON35669niversitair Medisch Centrum Utrecht15
尚未招募
Unknown
Prophylactic use of glucocorticoids to reduce postoperative delirium in adult patients: A systematic review with meta-analysisAdult patients who underwent surgeryJPRN-UMIN000052979Teikyo University School of Medicine, Mizonokuchi Hospital1,000
进行中（未招募）
1 期
Prevention of Glucocorticoid induced impairment of bone metabolism – A Randomized, Placebo-Controlled, Single Centre Clinical TrialOral glucocorticoid (GC) therapy leads to a rapid and profound effects on bone metabolism.The gut microbiota is involved in regulating bone metabolism.Lactobacillus reuteri (LR) has been shown to have probiotic, health-promoting effects.The aim of this randomized, double-blind, placebo-controlled trial is to investigate if daily supplementation with LR, compared to placebo, can prevent the negative effects of oral GC on bone turnover and on blood glucose regulation in healthy young adults.EUCTR2021-000275-36-SESahlgrenska University Hospital50