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
Protocol serial number	PB-PG-0609-19093
Sponsor	University of Birmingham (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme

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

Primary study design	Interventional
Study design	Phase 1: Quantitative study, Phase 2: Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	Beta cell function-measured using a meal stimulate C peptide assay at the study onset, 6 months and 12 months time intervals.
Completion date	31/12/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Institute of Biomedical Research

Birmingam
B15 2TT
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/01/2018		Yes	No
Protocol article	protocol	18/06/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/02/2018: Publication reference added.