n-3 Fatty Acid Infusion and Type 2 Diabetes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes|
- insulin sensitivity [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- n-3 fatty acid distribution [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- insulin secretion [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- energy metabolism [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- oxidative stress [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
|Study Start Date:||January 2004|
|Study Completion Date:||October 2008|
|Primary Completion Date:||May 2004 (Final data collection date for primary outcome measure)|
Experimental: Intralipid with/without Omegaven
Lipid infusion with/without marine n-3 fatty acids
Dietary Supplement: Intralipid +/- Omegaven
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829569
|Department of Medicine, Division of Endocrinology, St. Olavs Hospital|
|Trondheim, Norway, N-7006|
|Principal Investigator:||Valdemar Grill, M.D.||St. Olavs Hospital, NTNU|