Prevention of hyperglycaemia and vascular risk factors in patients with Type 1 diabetes mellitus Nutritional, Metabolic, Endocrine Type 1 diabetes mellitus
Conditions
Interventions
Current interventions as of 12/05/2021:
Participants will attend two laboratory-based visits each interspersed by a minimum of one week. On each occasion participants will undergo one of two experimen
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 1 diabetes for a minimum of 5 years 2. Aged between 18-60 years 3. Currently being treated on a stable insulin regimen for =6 months consisting of continuous subcutaneous insulin infusion (CSII) or multiple daily insulin (MDI) of a combination of rapid-acting and long-acting insulin 4. Able to understand written English and provide a written consent form 5. Do not currently meet the recommendations for moderate-to-vigorous physical activity (150 min/week) in adults
Exclusion criteria
Exclusion criteria: 1. Newly diagnosed with T1D (<5 years) 2. Not on a stable insulin regimen consisting of CSII or MDI of a combination of rapid-acting and long-acting insulin 3. Currently pregnant or seeking to become pregnant within study timelines 4. Diagnosed with overt diabetes complications (except for mild retinopathy) 5. Presenting with hypoglycaemia unawareness 6. Established and/or diagnosed medical conditions (e.g. haematological disorder, gut mobility or digestion) 7. History of eating disorders (e.g. anorexia, bulimia) 8. History of deep vein thrombosis 9. History of stroke or heart attack (within 6 months before recruitment) 10. History of malignancy 11. History of existing medical or psychiatric conditions 12. Recent history of diabetic ketoacidosis (<6 months) 13. Severe functional limitations (e.g. back pain, and walking difficulties) 14. Dietary allergies or intolerance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 12/05/2021: 48 h glycaemic control measured using continuous glucose monitoring for 48 h before and after each laboratory visit Previous primary outcome measure: 48 h glycaemic control measured using continuous glucose monitoring for 48 h prior to the intervention and for 48 h after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Vascular inflammatory responses to each intervention measured using biochemical analysis techniques at baseline and 1, 2, 3, 4, 5, 6, and 7 h during the laboratory observation window | — |
Countries
England, United Kingdom
Outcome results
None listed