Can exercise reduce disease activity in people with type 1 diabetes?
- Conditions
- Type 1 diabetesNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN79006041
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39224197/ (added 03/09/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method