Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial - Adolescent Diabetes Intervention Trial (AdDIT)

Phase 1

• Conditions: Type 1 diabetes in adolescents; MedDRA version: 14.0 Level: LLT Classification code 10012609 Term: Diabetes mellitus juvenile onset System Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.0 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2007-001039-72-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust, jointly with University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-07
• Study Completion: 2017-01-18
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 443

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified