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A randomised controlled trial of the benefits of exercise early in the management of Type 2 diabetes
ISRCTN ISRCTN92162869
DOI 10.1186/ISRCTN92162869
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of the benefits of exercise early in the management of Type 2 diabetes
Scientific title
Acronym The Early ACTID Study
Serial number at source N/A
Study hypothesis An ideal treatment for diabetes would improve glycaemic control by decreasing insulin resistance and improving insulin secretion without the side effect of weight gain. To date no pharmacological agents have been able to satisfy all of these criteria. In contrast, increased physical activity has the potential to offer all of these benefits with little or no side-effects. Hence it should represent the ideal first line treatment for Type 2 diabetes and for maximal benefit should be instituted early. Whilst we know that lifestyle intervention can be an effective treatment for those individuals with impaired glucose tolerance, i.e. in a pre-diabetic state, what we seek to establish is whether increased physical activity (using a simple home-based exercise programme) and dietary changes can alter the course of established type 2 diabetes.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Type 2 diabetes
Participants - inclusion criteria This a multicentre trial recruiting 750 participants from across the South West of England. Individuals must satisfy the following criteria before they can be considered eligible:
1. Type 2 diabetes mellitus (T2DM) as defined by: body mass index (BMI) >25, no ketosis, no significant weight loss prior to diagnosis, aged above 30 at diagnosis
2. Between 5 and 8 months from clinical diagnosis of T2DM
Participants - exclusion criteria 1. Age over 80 at diagnosis
2. HbA1c of greater than 10%
3. Blood pressure greater than 180/100
4. Low-density lipoprotein (LDL) greater than 4
5. Patients already receiving a maximum dose of a sulphonylurea
6. Have a current diagnosis of unstable angina
7. Have had a myocardial infarction within the previous three months
8. Unable to increase their physical activity
9. Subject is pregnant or is of childbearing age and not surgically sterile, 2 years postmenopausal or does not practice one method of contraception
Anticipated start date 01/07/2005
Anticipated end date 31/07/2008
Status of trial Completed
Patient information material
Target number of participants 750
Interventions 1. Intensive dietary intervention
2. Increased exercise and intensive dietary intervention
3. Control: Usual Care

Individuals recruited into all 3 arms of the trial will have their diabetes and blood pressure management taken over by Early ACTID for the duration of the trial. Both intervention arms are based on regular counselling sessions with a research nurse and/or dietitian to encourage changes to the patients lifestyle.
Primary outcome measure(s) Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months.
Secondary outcome measure(s) Lipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months.
Sources of funding 1. Diabetes UK (UK) (ref: BDA:R04/0002750)
2. National Health Service (NHS) (UK) - ad hoc funding
Trial website
Publications 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21705068
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24811615
Contact name Dr  Robert  Andrews
  Address Joint Clinical Research Unit
Level 5, Old Building
Bristol Royal Infirmary
Marlborough Street
  City/town Bristol
  Zip/Postcode BS2 8HW
  Country United Kingdom
  Tel +44 (0)117 9282440
  Fax +44 (0)117 9284470
  Email rob.andrews@bristol.ac.uk
Sponsor University of Bristol (UK)
  Address Gillian Tallents
Research Governance Manager
University of Bristol
Research & Enterprise Development
Senate House
Tyndall Avenue
  City/town Bristol
  Zip/Postcode BS2 8HW
  Country United Kingdom
  Tel +44 (0)117 9546966
  Fax +44 (0)117 9298383
  Email Gillian.Tallents@bristol.ac.uk
Date applied 21/02/2005
Last edited 12/05/2014
Date ISRCTN assigned 25/07/2005
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