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Completed

NCT Number: NCT01581476

Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial

The purpose of this study is to determine whether use of blood pressure lowering drugs, Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs (statins) may have a place in the treatment of adolescents with diabetes and can help reduce serious long-term health problems in this population.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Western Australia, Perth, Australia

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About this study

Subjects will be recruited from a pre-screened population of 3,000 young people with T1D aged 10 to 16 years based on assessment of risk for future CVD and DN.

They will be randomised to a 2 x 2 factorial design contrasting the effects of ACEI, statins, or combination therapy to placebo over a maximum four year treatment period. Minimisation of variation in albumin excretion rate, gender, age, diabetes duration, HbA1c, total cholesterol and centre site will be undertaken at randomisation.

Analysis of the primary endpoint, change in albumin excretion will be undertaken on an intention to treat basis. Secondary analyses will be undertaken on the basis of 'as treated' allowing for variance in compliance and allowing for subjects who show substantial change in HbA1c levels. Additional analyses will be undertaken to assess changes in the secondary objectives and to assess the overall effect of the intervention on quality of life and health economics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 10 to 16 years.
  • T1D diagnosed for more than 1 year or C-peptide negative.
  • Centralised assessment of ACR 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.

Exclusion criteria

  • Non T1D, i.e. type 2 diabetes, insulin dependent diabetes related to monogenic disease, secondary diabetes.
  • ACR based on six early morning urines deemed to be at low risk for subsequent development of CVD or DN.
  • Pregnancy or unwillingness to comply with contraceptive advice and regular pregnancy testing throughout the trial.
  • Breast feeding
  • Severe hyperlipidaemia and family history data to support diagnosis of familial hypercholesterolaemia.
  • Established hypertension unrelated to DN.
  • Prior exposure to the investigational products, statins and ACEI.
  • Unwillingness/inability to comply with the study protocol.
  • Other co-morbidities considered unsuitable by the investigator (excluding treated hypothyroidism and coeliac disease).
  • Proliferative retinopathy.
  • Renal disease not associated with Type 1 Diabetes.

Treatment and study plan

Statin

Drug

10mg daily for a minimum period of 2 years

Other names: Atorvastatin

ACE inhibitor

Drug

Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.

Other names: Quinapril

Placebo

Drug

Participants receive statin placebo and ACEI placebo

Combination therapy

Drug

Participants receive both active statin and active ACEI. Dose for Statins is 10mg daily. Dosing for ACEI starts at 5mg daily rising to 10mg after 14 days providing it is well tolerated. Both interventions last for a minimum of 2 years.

Other names: Atorvastatin, Quinapril

Primary outcomes

  1. Albumin creatinine ratio

    Time frame: 2-4 years treatment duration

    The area under the curve over time of log ACR per year, with standardisation for gender, age and duration of disease

Secondary outcomes

  1. Changes in CVD risk markers

    Time frame: 2-4 yrs treatment duration

    Changes in measures of:

    • cIMT, FMD, EndoPAT and PWV between baseline and the end of intervention period;
    • arterial BP, lipids and other lipoproteins, CVD risk markers (hsCRP and ADMA), assessed every 6 months during the intervention period.

  2. Changes in glomerular filtration rate (GFR)

    Time frame: 2-4 years treatment duration

    Changes in measures of GFR (plasma SDMA, creatinine adn cystatin C levels) assessed every 6 months during intervention period.

  3. Retinopathy

    Time frame: 2-4 years treatment duration

    Changes in retinopathy scores and retinal microvascular structure (arteriolar or venular dilation, vascular fractile dimension, branching and tortuosity) assessed annually

  4. Quality of Life and Health Economics

    Time frame: 2-4 years treatment duration

    Changes in quality of life measures and resource usage

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • British Heart Foundation
  • Diabetes UK
  • Juvenile Diabetes Research Foundation
  • Pfizer
  • St Thomas' Hospital, London
  • The Hospital for Sick Children
  • The University of Western Australia
  • University of Oxford

Registry information

Official study title

Randomised, Double Blind, Placebo Controlled Trial of Angiotensin Converting Enzyme Inhibitors and Statins in the Prevention of Long Term Complications in Young People With Type 1 Diabetes

Acronym: AdDIT

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2012
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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