n-3 Fatty Acid Infusion and Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Intralipid +/- Omegaven


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intralipid with/without Omegaven<br>Lipid infusion with/without marine n-3 fatty acids | Dietary Supplement: Intralipid +/- Omegaven<br>* 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).<br>* Other names: Omegaven Vnr 55 25 54;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity |  | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| n-3 fatty acid distribution |  | 4 hours | 
| insulin secretion |  | 4 hours | 
| energy metabolism |  | 4 hours | 
| oxidative stress |  | 4 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intralipid, Omegaven, fish oil, hyperinsulinemic isoglycemic clamps, C-peptide glucagon test, indirect calorimetry, F2-isoprostanes