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

Institute of Biomedical Research
University of Birmingham
Edgbaston
Birmingam
B15 2TT
United Kingdom

Study information

Study designPhase 1: Quantitative study, Phase 2: Randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleIncreasing physical exercise to preserve beta cell function in adult patients with type 1 diabetes mellitus (T1DM): a randomised controlled trial
Study acronymT1DM
Study objectivesIntensive 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) studiedType 1 diabetes mellitus
InterventionExercise 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 typeOther
Primary outcome measure1. 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 measuresBeta cell function-measured using a meal stimulate C peptide assay at the study onset, 6 months and 12 months time intervals.
Overall study start date01/04/2011
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants92
Key inclusion criteria1. 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 criteria1. 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 enrolment01/04/2011
Date of final enrolment31/12/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Biomedical Research
Birmingam
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

University of Birmingham
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website http://www.rcs.bham.ac.uk
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.