Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of type 2 diabetes mellitus 2. Aged 30 to 70 years 3. Do not currently engage in 150-minutes of moderate-to-vigorous physical activity per week (assessed by the Get Active Questionnaire; CSEP 2017) 4. Cleared for engaging in physical activity by their General Practitioner 5. Can read, write and speak English
Exclusion criteria
Exclusion criteria: 1. Currently taking exogenous insulin 2. Uncontrolled hypertension (systolic blood pressure (BP) > 160 mmHg and/or diastolic BP > 90 mmHg), for which the individual is not taking medication 3. Myocardial infarction or stroke within the past six months or evidence of end-stage renal failure or liver disease 4. Any other contra-indications to exercise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of the intervention and research methods assessed through measurement of: 1. Recruitment to the trial 2. Willingness of participants to be randomized 3. Retention rates 4. Adherence to the intervention and research procedure methods including data collection 5. Intervention fidelity 6. Participants experiences of being part of the trial These outcomes will be measured at the end of the study. Recruitment, willingness to be randomized, retention rates and intervention fidelity will be descriptively described. Adherence to intervention and research procedures will be measured through calculating the number of participants who complete each research procedure. Participants experiences of being part of the trial will be assessed through analysis of data collected through qualitative interviews conducted after post-intervention testing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: 1. BMI and waist circumference measured at pre and post intervention 2. Glycated haemoglobin, glucose, insulin, lipids and C-reactive protein and response to an oral glucose tolerance test measured at pre and post intervention 3. Health-related quality of life measured using the short form SF-36 collected at pre and post intervention Tertiary outcome measures: Physiological mechanistic outcome measures: 1. Cardiorespiratory fitness measured using a continuous incremental ramp maximal exercise test pre and post intervention 2. Body composition measured using dual energy X-ray absorptiometry at pre and post intervention 3. Muscle quality, density and area measured using peripheral quantitative computer tomography pre and post intervention Behavioural outcome measures: 1. E-cycling activity measured using a GPS device throughout the intervention 2. Total physical activity measured using accelerometers pre and just before the end of the intervention 3. Travel behaviour measured using GPS pre and just before the end of the intervention Psychological outcome measures: 1. Barriers and facilitators to e-cycling assessed through qualitative interviews post intervention | — |
Countries
England, United Kingdom
Outcome results
None listed