EXTOD Immune

Recruiting until: April 2023

Can a remotely monitored, home-based exercise intervention for individuals with type-one diabetes reduce immune driven disease activity? (EXTOD-Immune)

Recruiting sites:

  • Queen Elizabeth Hospital, University Hospitals Birmingham
  • Musgrove Park Hospital, Somerset NHS Foundation Trust (opening soon)
  • School of Sport and Exercise Sciences, Liverpool John Moores University

Summary:

The project is for patients with type-1 diabetes (diagnosed within 1 year) who are not physically active. Patients will be asked to undertake an exercise intervention for 12 weeks in their own home, followed by a 12-week break and then a 12-week control period with no prescribed exercise.

Aim

The aim of this project is to investigate the impact of a remotely monitored exercise intervention on immune driven disease activity in patients with a recent diagnosis of type-1 diabetes vs. standard care with no prescribed exercise.

Eligibility to take part

Inclusion Criteria

  • Age: 18-60 years old
  • Clinical diagnosis of T1D made within the last 1 year
  • Self‐administering their insulin as part of a multiple dose injection regime or insulin pump therapy.
  • Both participant and physician feel that they are able to exercise safely.
  • Patient is able to estimate carbohydrate content of meals
  • Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly
  • Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L

Exclusion Criteria

  • Uncontrolled blood pressure
  • Pregnancy or planning pregnancy
  • Adhering to the current recommended physical activity guidelines (> 150 minutes)
  • Additional health conditions that might put the participant at risk for this study e.g. heart disease, diabetic complication or a history of severe hypoglycaemia requiring third party assistance within the last 3 months.
  • Unable to provide full informed consent.

If you are interested in taking part, please click the “Get Involved” button below:

Get Involved

What will I be asked to do?

If you agree to take part in the study and meet the inclusion criteria after our initial screening (conducted remotely, including a saliva sample), you will be invited to attend your local Clinical Research Facility (CRF) on four separate occasions over a 36-week period. On each visit, we will carry out a medical review and measure your weight, blood pressure, pulse and draw a blood sample. We will also ask you to wear a continuous glucose monitor for 2 weeks. You will then be randomly allocated to either a home-based exercise or control group (undertake your usual level of exercise without any extra support from us) between weeks 1-12. Following a 12-week break from the study, you will be allocated to the other group in weeks 24-36. Please see a simplified study schematic below:

The exercise is safe for people with type-1 diabetes to undertake at home. Details are outlined below:

  1. For weeks 1-2 of the intervention, we will ask participants to:
    • Perform a low intensity warm up for 2-minutes
    • Perform 6 x 1-minute high intensity intervals (bodyweight exercises), interspersed with 1-minute rest intervals (11 minutes). You will be asked to exercise at an intensity that elicits 80% of your maximum heart rate.
    • Total exercise time will be 13 minutes.
  2. For weeks 3-4 of the intervention, this will increase to 8 intervals (total exercise time will be 17 minutes).
  3. For weeks 5-12 of the intervention, this will increase to 10 intervals (total exercise time will be 21 minutes).

Who is running this study?

Sponsor: University of Birmingham

Chief Investigator: Dr Alex Wadley

Funder: The Rosetrees Trust

Study site: Central site is University of Birmingham, but study sites available nationally