title: Exercise to preserve beta cell function in recent-onset type 1 diabetes mellitus (EXTOD)--a study protocol for a pilot randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current controlled trials ISRCTN91388505.
authors.affiliation: Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
authors.forename: Nadia
authors.initials: N
authors.lastname: Lascar
authors.forename: Amy
authors.initials: A
authors.lastname: Kennedy
authors.forename: Nikki
authors.initials: N
authors.lastname: Jackson
authors.forename: Amanda
authors.initials: A
authors.lastname: Daley
authors.forename: George
authors.initials: G
authors.lastname: Dowswell
authors.forename: Dylan
authors.initials: D
authors.lastname: Thompson
authors.forename: Keith
authors.initials: K
authors.lastname: Stokes
authors.forename: Sheila
authors.initials: S
authors.lastname: Greenfield
authors.forename: Roger
authors.initials: R
authors.lastname: Holder
authors.forename: Rob
authors.initials: R
authors.lastname: Andrews
authors.forename: Parth
authors.initials: P
authors.lastname: Narendran
mesh_terms: D015415:Biomarkers / Q000097:blood; D002096:C-Peptide / Q000097:blood; D002985:Clinical Protocols; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D018450:Disease Progression; D004739:England; D005081:Exercise Therapy; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D050417:Insulin-Secreting Cells / Q000378:metabolism*; D009042:Motivation; D010349:Patient Compliance; D018579:Patient Selection; D010809:Physical Fitness; D010865:Pilot Projects; D019518:Postprandial Period; D012107:Research Design; D040242:Risk Reduction Behavior; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002096:C-Peptide; D007004:Hypoglycemic Agents