Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PB-PG-0609-19093
Study information
Scientific title
Increasing physical exercise to preserve beta cell function in adult patients with type 1 diabetes mellitus (T1DM): a randomised controlled trial
Acronym
T1DM
Study hypothesis
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
Birmingham, East, North and Solihull Research Ethics Committee, February 2010, ref: 10/H1206/4
Study design
Phase 1: Quantitative study, Phase 2: Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/04/2011
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
92
Participant 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
Recruitment start date
01/04/2011
Recruitment end date
31/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Biomedical Research
Birmingam
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2013 protocol in www.ncbi.nlm.nih.gov/pubmed/23777480
2. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29371269
Publication citations
-
Protocol
Lascar N, Kennedy A, Jackson N, Daley A, Dowswell G, Thompson D, Stokes K, Greenfield S, Holder R, Andrews R, Narendran P, Exercise to preserve beta cell function in recent-onset type 1 diabetes mellitus (EXTOD)--a study protocol for a pilot randomized controlled trial., Trials, 2013, 14, 180, doi: 10.1186/1745-6215-14-180.