Chronic omega-3 fatty acid supplementation in type 1 diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN40811115
• Lead Sponsor: eeds Beckett University

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32787879/ results (added 17/08/2020) 2022 Results article in https://doi.org/10.1177/14791641221103217 (added 19/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-27
• Study Completion: 2019-09-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

None.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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