Diabetic nephropathy and cardiovascular disease Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
AdDIT:
Eligible subjects who have provided informed consent and have completed baseline assessments are randomized using a secure internet-based service (www.sealedenvelope.com). This
if there have been no adverse reactions in this time, the dose is increased to 10 mg daily, otherwise it will maintained at 5 mg. Any subjects experiencing apparent side effects (postural hypotension
Sponsors
University of Cambridge and Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AdDIT: 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
Exclusion criteria: AdDIT: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AdDIT: The primary endpoint is defined as the area under the curve over time of log albumin-creatinine ratio per year, with standardisation for gender, age and duration of disease. AdDIT follow up: Prevalence of vascular complications at the end of the 5 year follow-up period, specifically: 1. The prevalence of Micro/macroalbuminuria, as assessed by urinary albumin creatinine ratio (ACR) 2. The prevalence of retinopathy, as assessed by retinal imaging 3. The prevalence of decline in renal function, as assessed by markers such as cystatin C, SDMA, creatinine-based glomerular filtration rate 4. The prevalence of early signs of macrovascular disease, as assessed by direct vascular measures, such as PWV, cIMT, FMD | — |
Secondary
| Measure | Time frame |
|---|---|
| AdDIT: 1. Changes in carotid intimal media thickness, between baseline and the end of intervention period 2. Changes in arterial Blood Pressure (BP), lipids and other lipoproteins, CVD risk markers (high-sensitive C-Reactive Protein [hsCRP] and Asymmetric Dimethylarginine [ADMA]), assessed every six months during the intervention period 3. Changes in measures of Glomerular Filtration Rate (GFR) (plasma Symmetrical Dimethylarginine [SDMA], creatinine and cystatin C) assessed every six months during the intervention period 4. Changes in quality of life and health economics AdDIT follow up: Tracking of ACR, lipid levels, blood pressure, abnormal inflammatory markers during the 5-year follow up period, based on yearly assessments. | — |
Countries
Australia, Canada, England, United Kingdom
Outcome results
None listed