Type 1 Diabetes Nutritional, Metabolic, Endocrine Type 1 Diabetes
Conditions
Interventions
Participants are randomized (using a commuter automated programme) to one of two treatment groups (n3-FA supplementation or placebo control).
Arm 1 Supplementation: Participants receive the n3-FA sup
Sponsors
Leeds Beckett University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 01/04/2020: 1. Male or female and aged 18-65 years old 2. Free from any diabetes-related complications (except background diabetic retinopathy) 3. Not known to be allergic or sensitive to fish, fish oil, or n3-FA products 4. Not known to have or have had documented atrial fibrillation 5. Not known to have documented liver problems or abnormal liver function 6. Will not be pregnant, planning to become pregnant within 12 months, or currently breastfeeding 7. Not known to have documented hematological abnormalities or experience heavy menstrual bleeding 8. Not taking prescribed medication knowing to interfere with study procedures 9. Treated with a stable insulin regimen composed of either: 9.1. A combination of slow/long-acting insulin glargine/detemir and a fast-acting insulin analogue lispro/aspart/glulisine 9.2. Continuous subcutaneous insulin infusion therapy (insulin pump therapy) 10. Have an HbA1c of <11% (97 mmol/mol) 11. Using the carbohydrate counting method for administering meal-time insulin Previous inclusion criteria: 1. Male or female and aged 18-65 years old 2. Free from any diabetes-related complications (except background diabetic retinopathy) 3. Not known to be allergic or sensitive to fish, fish oil, or n3-FA products 4. Not known to have or have had documented atrial fibrillation 5. Not known to have documented liver problems or abnormal liver function 6. Will not be pregnant, planning to become pregnant within 12 months, or currently breastfeeding 7. Not known to have documented hematological abnormalities or experience heavy menstrual bleeding 8. Not taking any prescribed medication other than insulin 9. Treated with a stable insulin regimen composed of either: 9.1. A combination of slow/long-acting insulin glargine/detemir and a fast-acting insulin analogue lispro/aspart/glulisine 9.2. Continuous subcutaneous insulin infusion therapy (insulin pump therapy) 10. Have an HbA1c of <11% (97 mmol/mol) 11. Using the carbohydrate counting method for administering meal-time insulin
Exclusion criteria
Exclusion criteria: None.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Blood glucose is measured using the Biosen C-Line at 30 minutes intervals throughout an 8-hour observation window at baseline, three, six and nine months 2. Blood lipid/fat is measured using the biochemical analysis (Elisa/Essay technique) at 30 minutes intervals throughout an 8-hour observation window at baseline, three, six and nine months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Inflammatory responses to mixed meals that are high in carbohydrate and fat, following n3-FA supplementation is measured using biochemical analysis (Elisa/Essay technique) at 30-minutes intervals throughout an 8-hour observation window at baseline, three, six and nine months 2. Vascular responses to mixed meals that are high in carbohydrate and fat, following n3-FA supplementation is measured using vascular imagining techniques at baseline, between 3-4 hours post-breakfast, and between 7-8 hours post-breakfast at baseline, three, six and nine months 3. Long-term resting glycaemic, lipaemic, inflammatory, and vascular responses to chronic n3-FA supplementation are measured using biochemical analysis (Elisa/Essay technique) at baseline, 3-months, and 6-months post intervention 4. Glycaemic, lipaemic, inflammatory, and vascular responses to chronic n3-FA supplementation following 3-months washout are measured using biochemical analysis (Elisa/Essay technique) and vascular scanning techniques at 9-months post intervention 5. Compliance and adherence towards n3-FA supplementation is measured using EHA and DHA from plasma/serum at baseline, 3-months, 6-months, and 9-months 7. Facilitators to n3-FA supplementation is measured using a non-validated questionnaire at baseline 8. Barriers to n3-FA supplementation is measured using a non-validated questionnaire at baseline 9. Quality of life is measured using a non-validated questionnaire at baseline, 3-months, 6-months, and 9-months post-intervention | — |
Countries
England, United Kingdom
Outcome results
None listed