Increasing physical exercise to preserve beta cell function in adult patients with type 1 diabetes mellitus (T1DM)

Conditions

Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Amy Kennedy, Parth Narendran, Robert Andrews, Amanda Daley, Sheila Greenfield

BMJ Open2018-01-0179 citations

10.1136/bmjopen-2017-017813

Exercise to preserve β‐cell function in recent‐onset Type 1 diabetes mellitus (<scp>EXTOD</scp>) – a randomized controlled pilot trial

Parth Narendran, Nancy A Jackson, Amanda Daley, David R. Thompson, Keith Stokes et al. (16 authors)

Diabetic Medicine2017-09-1449 citations

10.1111/dme.13439

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

Lascar N, Kennedy A, Jackson N, Daley A, Dowswell G, Thompson D, Stokes K, Greenfield S, Holder R, Andrews R, Narendran P.

2013-06-1812 citations

10.1186/1745-6215-14-180

Interventions

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)

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Beta cell function-measured using a meal stimulate C peptide assay at the study onset, 6 months and 12 months time intervals.	—

Countries

United Kingdom

Outcome results

None listed