Increasing physical exercise to preserve beta cell function in adult patients with type 1 diabetes mellitus (T1DM)
| ISRCTN | ISRCTN91388505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91388505 |
| Secondary identifying numbers | PB-PG-0609-19093 |
- Submission date
- 21/04/2011
- Registration date
- 18/10/2011
- Last edited
- 14/02/2018
- 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 Parth Narendran
Scientific
Scientific
Institute of Biomedical Research
University of Birmingham
Edgbaston
Birmingam
B15 2TT
United Kingdom
Study information
| Study design | Phase 1: Quantitative study, Phase 2: Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Increasing physical exercise to preserve beta cell function in adult patients with type 1 diabetes mellitus (T1DM): a randomised controlled trial |
| Study acronym | T1DM |
| Study objectives | Intensive exercise preserves beta cell function in patients with T1DM On 04/10/2013, the anticipated end date was changed from 31/03/2013 to 31/12/2014. |
| Ethics approval(s) | Birmingham, East, North and Solihull Research Ethics Committee, February 2010, ref: 10/H1206/4 |
| Health condition(s) or problem(s) studied | Type 1 diabetes mellitus |
| Intervention | Exercise will be supervised, graded and for a minimum of 150 min/week aiming for 240 min/week over a 1-year period versus control group (no exercise) |
| Intervention type | Other |
| Primary outcome measure | 1. The proportion of patients with T1DM who started the intervention 2. The proportion who adhered to the required intensity of exercise 3. The proportion who dropped out 4. The rate of exercise uptake in the non-intervention arm, an effect which is important to incorporate into the trial design because it will dilute the effect of the intervention observed within the trial 3. The rates of loss of beta cell function (effect size) in the intervention and control arm to enable the power calculations for the definitive trial to be refined |
| Secondary outcome measures | Beta cell function-measured using a meal stimulate C peptide assay at the study onset, 6 months and 12 months time intervals. |
| Overall study start date | 01/04/2011 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 92 |
| Key inclusion criteria | 1. A clinical diagnosis of T1DM made within the previous 3 months 2. Age 16-60 years at time of diagnosis 3. Willing to monitor and adjust insulin in order to safely undertake exercise programme |
| Key exclusion criteria | 1. Pregnancy 2. Inability to give informed consent 3. Inability or unwilling to exercise 4. Any psychological disease likely to interfere with the conduct of the study 5. Patients on beta blocker therapy or other therapies that affect heart rate |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Biomedical Research
Birmingam
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.rcs.bham.ac.uk |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 18/06/2013 | Yes | No | |
| Results article | results | 24/01/2018 | Yes | No |
Editorial Notes
14/02/2018: Publication reference added.
