n-3 Fatty Acid Infusion and Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Intralipid +/- Omegaven

• Registration Number: NCT00829569
• Lead Sponsor: St. Olavs Hospital

Brief Summary

The purpose of this experimental study is to investigate whether an acute lipid infusion added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2 diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids. Furthermore other effects on intermediary metabolism are tested for.

Detailed Description

Evidence indicates that n-3 fatty acids exert several beneficial effects. However, the effects of marine n-3 fatty acids on intermediary metabolism have not been completely elucidated. In a previous study of a high intake of marine n-3 fatty acids during 9 wk we demonstrated reduced insulin sensitivity and altered proportion of carbohydrate vs. fat oxidation in subjects with type 2 diabetes. These results question the use of high doses of n-3 supplements in type 2 diabetes. It is not known to what extent such effects in type 2 diabetes can be reproduced by intravenous administration of n-3 fatty acids and/or whether short term intravenous administration has other effects.

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2004-05
• Study Completion: 2008-10
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-03
• Last Update Posted: 2011-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Type 2 diabetes defined by clinical criteria and by absence of antibodies to glutamic acid decarboxylase.
• HbA1c 5,5 - 8,5 %
• Blood pressure ≤ 170 mm Hg systolic and/or ≤ 105 mm Hg diastolic

Exclusion Criteria

• insulin treatment
• hypertriglyceridemia (> 2,1 mmol/l TG)
• proliferative retinopathy, renal insufficiency (Se-Creatinine > 150 μmol/l)
• alcoholism, congestive heart failure or other serious diseases affecting the possibility of the subject to participate
• supplement with fish oil or marine n-3 fatty acids during the last 6 months before baseline
• Dicumarol treatment
• allergy to soya, fish or egg
• pregnancy or lactation
• smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intralipid with/without Omegaven	Intralipid +/- Omegaven	Lipid infusion with/without marine n-3 fatty acids

Primary Outcome Measures

Name	Time	Method
insulin sensitivity	4 hours

Secondary Outcome Measures

Name	Time	Method
oxidative stress	4 hours
n-3 fatty acid distribution	4 hours
insulin secretion	4 hours
energy metabolism	4 hours

Trial Locations

Locations (1)

Department of Medicine, Division of Endocrinology, St. Olavs Hospital; 🇳🇴 Trondheim, Norway