EUCTR2007-001039-72-GB
Active, not recruiting
Phase 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 enrollmentJanuary 7, 2008
ConditionsType 1 diabetes in adolescentsMedDRA version: 14.0 Level: LLT Classification code 10012609 Term: Diabetes mellitus juvenile onset System Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 10027433 - Metabolism and nutrition disorders
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 1 diabetes in adolescents
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust, jointly with University of Cambridge
- Enrollment
- 443
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
Outcomes
Primary Outcomes
Not specified
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