n-3 Fatty Acid Infusion and Type 2 Diabetes

St. Olavs Hospital

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Intralipid +/- Omegaven

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00829569

4.2003.169

03-14463 (Other Identifier)

15759 (Other Identifier)

03/05008 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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11 participants in 1 patient group

Intralipid with/without Omegaven

Experimental group

Description:

Lipid infusion with/without marine n-3 fatty acids

Treatment:

Dietary Supplement: Intralipid +/- Omegaven