n-3 Fatty Acid Infusion and Type 2 Diabetes

St. Olavs Hospital11 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Intralipid +/- OmegavenDIETARY_SUPPLEMENT

Intralipid®: the 500 ml 20% Intralipid will be infused during a hyperinsulinemic clamp. Infusion rate will increase from 50 to 100 ml/hour the first 30 min and then continue at 100 ml/hour for the next 210 min, infusion duration 240 min (4 hours) in all. Intralipid® + Omegaven®: In the 500 ml 20% Intralipid 100 ml will be replaced by 100 ml 10% Omegaven and infused during the hyperinsulinemic clamp as described for Intralipid only. Heparin (0.4 U/kg/min) will be added to both lipid emulsions. Content of marine n-3 fatty acids in 100 ml Omegaven will be 1.25-2.82 g EPA and 1.44-3.09 g DHA (seasoning variations of n-3 fatty acids in fish oil).

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Medicine, Division of Endocrinology, St. Olavs Hospital

Trondheim, Norway

Outcomes

Primary Outcomes

insulin sensitivity

Time frame: 4 hours

Secondary Outcomes

n-3 fatty acid distribution

Time frame: 4 hours

insulin secretion

Time frame: 4 hours

energy metabolism

Time frame: 4 hours

oxidative stress

Time frame: 4 hours

Data from ClinicalTrials.gov

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