A randomised controlled trial of the benefits of exercise early in the management of Type 2 diabetes

ISRCTN	ISRCTN92162869
DOI	https://doi.org/10.1186/ISRCTN92162869
Secondary identifying numbers	N/A

Submission date: 21/02/2005
Registration date: 25/07/2005
Last edited: 19/04/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Robert Andrews
Scientific

Joint Clinical Research Unit
Level 5, Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 9282440
Email	rob.andrews@bristol.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	A randomised controlled trial of the benefits of exercise early in the management of Type 2 diabetes
Study acronym	The Early ACTID Study
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Type 2 diabetes
Intervention	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.
Intervention type	Other
Primary outcome measure	Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months.
Secondary outcome measures	Lipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months.
Overall study start date	01/07/2005
Completion date	31/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	750
Total final enrolment	593
Key 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
Key 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
Date of first enrolment	01/07/2005
Date of final enrolment	31/07/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Joint Clinical Research Unit

Bristol
BS2 8HW
United Kingdom

Sponsor information

University of Bristol (UK)
University/education

Gillian Tallents
Research Governance Manager
University of Bristol
Research & Enterprise Development
Senate House
Tyndall Avenue
Bristol
BS2 8HW
England
United Kingdom

Phone	+44 (0)117 9546966
Email	Gillian.Tallents@bristol.ac.uk
"ROR"	https://ror.org/0524sp257

Funders

Funder type

Charity

Diabetes UK (UK) (ref: BDA:R04/0002750)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): DIABETES UK LIMITED, British Diabetic Association
Location: United Kingdom

National Health Service (NHS) (UK) - ad hoc funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		09/07/2011		Yes	No
Other publications	Effect on inflammatory markers	08/05/2014		Yes	No
Other publications	Qualitative analysis of motivation	31/01/2018		Yes	No
Other publications	Analysis of association of glycaemic control with diet independent of weight change	18/04/2022	19/04/2022	Yes	No

Editorial Notes

19/04/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the results reference.
14/02/2018: Publication reference added.