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 |
| Protocol serial number | N/A |
| Sponsor | University of Bristol (UK) |
| Funders | Diabetes UK (UK) (ref: BDA:R04/0002750), National Health Service (NHS) (UK) - ad hoc funding |
- 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
Scientific
Joint Clinical Research Unit
Level 5, Old Building
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 9282440 |
|---|---|
| rob.andrews@bristol.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months. |
| Key secondary outcome measure(s) |
Lipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months. |
| Completion date | 31/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Joint Clinical Research Unit
Bristol
BS2 8HW
United Kingdom
BS2 8HW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
