Type 1 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Patients with new-onset type 1 diabetes will be randomised into a control group or validated home-based exercise program, each for a period of 12 weeks, separated by a 12-week washout period.
Exercis
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/11/2023: 1. Aged over 18 years 2. Clinical diagnosis of T1D made within the last 3 years 3. Confirmed clinical diagnosis of T1D 4. Confirmed HLA-A2*0201+ genotype 5. Self administering their insulin as part of a multiple dose injection regime or insulin pump therapy. 6. Both participant and physician feel that they are able to exercise safely. 7. Patient is able to estimate carbohydrate content of meals 8. Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly 9. Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L 10. Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions. 11. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent. _____ Previous inclusion criteria: 1. Aged over 18 years 2. Clinical diagnosis of T1D made within the last 1 year 3. Confirmed diagnosis of T1D via T1D-GRS2 4. Confirmed HLA-A2*0201+ genotype 5. Self administering their insulin as part of a multiple dose injection regime or insulin pump therapy. 6. Both participant and physician feel that they are able to exercise safely. 7. Patient is able to estimate carbohydrate content of meals 8. Patient is willing to test glucose and adjust insulin and carbohydrate doses accordingly 9. Patients will be able to recognise hypoglycaemic symptoms before capillary blood glucose falls to 3.5mmol/L 10. Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions. 11. Consent: demonstrates an understanding of the study and willingness to participate, as evidenced by voluntary written informed consent.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 14/11/2023: 1. Uncontrolled blood pressure 2. Pregnancy or planning pregnancy 3. Currently engaging in more than 150 minutes of exercise per week 4. Additional health conditions that might put the participant at risk for this study e.g. cardiac disease, active proliferative diabetic retinopathy, autonomic neuropathy and/or a history of severe hypoglycaemia requiring third party assistance within the last 3 months. Any other condition (medical or psychological) that is deemed inappropriate will be at the PI’s discretion. 5. Unable to provide full informed consent. _____ Previous exclusion criteria: 1. Uncontrolled blood pressure 2. Pregnancy or planning pregnancy 3. Adhering to the current recommended physical activity guidelines (> 150 minutes) 4. Additional health conditions that might put the participant at risk for this study e.g. cardiac disease, active proliferative diabetic retinopathy, autonomic neuropathy and/or a history of severe hypoglycaemia requiring third party assistance within the last 3 months. Any other condition (medical or psychological) that is deemed inappropriate will be at the PI’s discretion. 5. Unable to provide full informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| White blood cells with an affinity to degrade the pancreas will be measured using flow cytometry before and after the 12-week exercise and control periods | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. C-peptide will be measured using ELISA before and after the 12-week exercise and control periods 2. Autoantibodies will be measured using ELISA before and after the 12-week exercise and control periods 3. Insulin dose will be recorded before and after the 12-week exercise and control periods 4. HbA1c will be measured using an automated HbA1c analyser before and after the 12-week exercise and control periods 5. Cholesterol will be measured using an automated analyser before and after the 12-week exercise and control periods 6. Glycaemic control over a 2 week period will be measured by continuous glucose monitoring before and after the 12-week exercise and control periods 7. Blood pressure will be measured using a sphygmomanometer before and after the 12-week exercise and control periods 8. Levels of physical activity will be measured using the General practice physical activity questionnaire (GPPAQ) before and after the 12-week exercise and control periods 9. Barriers to exercise will be measured using the Barriers to physical activity in type-1 diabetes (BAPAD) questionnaire before and after the 12-week exercise and control periods 10. Health related quality of life will be measured using the Health related quality of life (EQ-5D) questionnaire before and after the 12-week exercise and control periods 11. Acceptability/ enjoyment of the intervention will be measured using a validated questionnaire after the exercise intervention | — |
Countries
England, United Kingdom
Outcome results
None listed