ISRCTN91419926
已完成
未知
Adolescent type 1 diabetes cardio-renal intervention trial
niversity of Cambridge and Cambridge University Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 500 人2007年10月3日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Diabetic nephropathy and cardiovascular disease
- 发起方
- niversity of Cambridge and Cambridge University Hospitals NHS Foundation Trust (UK)
- 入组人数
- 500
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
2009 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/20017932 protocol 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24198300 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35182158/ (added 21/02/2022)
研究者
入排标准
入选标准
- •1\. Type 1 diabetes diagnosed for greater than one year
- •2\. Aged 11 to 15 years
- •3\. High risk for the development of diabetic nephropathy and Cardiovascular Disease (CVD) as predicted by albumin excretion in the upper tertile after appropriate adjustment for age, sex, age at diagnosis and duration of disease
- •AdDIT follow\-up:
- •1\. Participants of the AdDIT Intervention and non\-intervention cohort
- •2\. Have given written informed consent to participate
- •3\. Have completed involvement in the AdDIT study
排除标准
- •1\. Non\-type 1 diabetes, i.e., type 2 diabetes, insulin dependent diabetes related to monogenic disease, secondary diabetes
- •2\. ACR based on six early morning urines deemed to be at low risk for subsequent development of CVD or diabetic nephropathy
- •3\. Pregnancy, or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial
- •4\. Severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia
- •5\. Established hypertension unrelated to diabetic nephropathy
- •6\. Prior exposure to the investigational products, statins and ACEI
- •AdDIT follow\-up:
- •1\. Inability to give consent
- •2\. Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of safety concern
结局指标
主要结局
未指定
相似试验
进行中（未招募）
1 期
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