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ISRCTN
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ISRCTN92162869
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of the benefits of exercise early in the management of Type 2 diabetes
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Scientific title
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Acronym
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The Early ACTID Study
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Type 2 diabetes
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2005
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Anticipated end date
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31/07/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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750
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Interventions
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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.
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Primary outcome measure(s)
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Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months.
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Secondary outcome measure(s)
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Lipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months.
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Sources of funding
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1. Diabetes UK (UK) (ref: BDA:R04/0002750)
2. National Health Service (NHS) (UK) - ad hoc funding
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21705068
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Contact name
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Dr
Robert
Andrews
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Address
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Joint Clinical Research Unit
Level 5, Old Building
Bristol Royal Infirmary
Marlborough Street
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Tel
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+44 (0)117 9282440
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Fax
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+44 (0)117 9284470
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Email
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rob.andrews@bristol.ac.uk
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Sponsor
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University of Bristol (UK)
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Address
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Gillian Tallents
Research Governance Manager
University of Bristol
Research & Enterprise Development
Senate House
Tyndall Avenue
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City/town
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Bristol
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Zip/Postcode
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BS2 8HW
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Country
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United Kingdom
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Tel
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+44 (0)117 9546966
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Fax
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+44 (0)117 9298383
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Email
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Gillian.Tallents@bristol.ac.uk
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Date applied
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21/02/2005
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Last edited
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06/09/2011
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Date ISRCTN assigned
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25/07/2005
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