ISRCTN91419926Completed未知
Adolescent type 1 diabetes cardio-renal intervention trial
niversity of Cambridge and Cambridge University Hospitals NHS Foundation Trust (UK)0 sites500 target enrollmentStarted: October 3, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 500
Study Overview
Brief Summary
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)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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