Exercise to preserve beta cell function in recent-onset type 1 diabetes mellitus (EXTOD) - a study protocol for a pilot randomized controlled trial

Nadia Lascar, Amy Kennedy, Nikki Jackson, Amanda Daley, George Dowswell, Dylan Thompson, Keith Stokes, Sheila Greenfield, Roger Holder, Rob Andrews, Partheepan Narendran

Research output: Contribution to journalArticlepeer-review

13 Citations (Scopus)
174 Downloads (Pure)

Abstract

Background
Exercise has a beta cell preserving effect in patients with type 2 diabetes. This benefit of exercise has not been examined in type 1 diabetes. Significant beta cell function is present at the time of diagnosis of type 1 diabetes and therefore studies of beta cell preservation are ideally conducted immediately after diagnosis.

Many of the variables required to design and power such a study are currently unknown. The aim of EXTOD is to obtain the information required to design a formal study of exercise and beta cell preservation in newly diagnosed patients with type 1 diabetes.

Methods
Barriers to exercise will initially be assessed in a qualitative study of newly diagnosed patients. Then, sixty newly diagnosed adult type 1 diabetes patients will be randomized to either conventional treatment or exercise, stratified on beta cell function and fitness. The exercise group will be encouraged to increase their level of activity to a minimum of 150 minutes of moderate to vigorous intensity exercise per week, aiming for 240 minutes per week of exercise for 12 months. Beta cell function will be measured by meal-stimulated C peptide. Primary outcomes are recruitment, adherence to exercise, loss to follow-up, and exercise levels in the non-intervention arm (contamination). The secondary outcome of the study is rate of loss of beta cell function.

Discussion
The outcomes of the EXTOD study will help define the barriers, uptake and benefits of exercise in adults newly diagnosed with type 1 diabetes. This information will enable design of a formal study to assess the effect of exercise on beta cell preservation in newly diagnosed patients with type 1 diabetes.

Trial registration
Current controlled trials ISRCTN91388505
Original languageEnglish
Article number180
JournalTrials
Volume14
Issue number1
DOIs
Publication statusPublished - 18 Jun 2013

Keywords

  • Exercise
  • Type 1 diabetes
  • Beta cell function
  • Physical activity
  • Barriers
  • Lifestyle
  • C peptide

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