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 - Metabo
Conditions
Interventions
Trade Name: Quinapril
Pharmaceutical Form: Tablet
INN or Proposed INN: QUINAPRIL
CAS Number: 85441618
Concentration unit: mg milligram(s
Sponsors
Cambridge University Hospitals NHS Foundation Trust, jointly with University of Cambridge
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, will reduce urinary albumin excretion, decline in renal function and the risk for diabetic nephropathy (DN) and cardiovascular disease (CVD); Secondary Objective: 1. Change in carotid artery intima-media thickness (cIMT) assessed at baseline and at the end of intervention period. 2. Longitudinal changes in blood pressure, blood lipids and lipoproteins 3. Changes in Glomerular Filtration Rate, as assessed by plasma symmetric dimethylarginine (SDMA), creatinine and cystatin C. 4. Longitudinal changes in CVD risk markers (hsCRP, ADMA). 5. Rates of microalbuminuria at the end of the intervention period and during the subsequent six month run-out period. 6. Quality of life and Health Economics. 7. The long term impact on renal and cardiovascular outcomes in the intervention group compared with placebo and compared with outcome in subjects screened but not recruited to the study. ; Primary end point(s): The primary endpoint is defined as the area under the curve over time of log standardised urinary Albumin/Creatinine ratio per year, with standardisation for gender, age and duration of disease. | — |
Countries
United Kingdom
Outcome results
None listed