EUCTR2007-001039-72-GBActive, not recruitingPhase 1
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial - Adolescent Diabetes Intervention Trial (AdDIT)
Cambridge University Hospitals NHS Foundation Trust, jointly with University of Cambridge0 sites443 target enrollmentStarted: January 7, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 443
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •1.Age 11 to 16 years.
- •2.Type 1 diabetes diagnosed for more than 1 year or C-peptide negative.
- •3.Centralised assessment of urinary albumin/creatinine ratio, based on six early morning urines deemed to be in upper tertile for risk after adjustment for age, gender, age at diagnosis and duration of disease.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.Non type 1 diabetes, ie type 2 diabetes, insulin dependent diabetes related to monogenic disease, secondary diabetes.
- •2.Urinary albumin/creatinine ratio based on six early morning urines deemed to be at low risk for subsequent development of CVD or DN.
- •3.Pregnancy, or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial.
- •4.Breast feeding.
- •5.Severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia.
- •6.Established hypertension unrelated to DN.
- •7.Prior exposure to the investigational products, statins and ACEI.
- •8. Unwillingness/inability to comply with the study protocol.
- •9. Other co-morbidities considered unsuitable by teh investigator (excluding treated hypothyroidism and coeliac disease).
- •10. Proloferative retinopathy.
Investigators
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