Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/04/2011
Date assigned
18/10/2011
Last edited
04/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Parth Narendran

ORCID ID

Contact details

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

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 measures

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

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

http://www.rcs.bham.ac.uk

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

Results - basic reporting

Publication summary

1. 2013 protocol in www.ncbi.nlm.nih.gov/pubmed/23777480

Publication citations

  1. 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.

Additional files

Editorial Notes