n-3 Fatty Acid Infusion and Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00829569|
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : November 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Dietary Supplement: Intralipid +/- Omegaven||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||May 2004|
|Actual Study Completion Date :||October 2008|
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).
- insulin sensitivity [ Time Frame: 4 hours ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829569
|Department of Medicine, Division of Endocrinology, St. Olavs Hospital|
|Trondheim, Norway, N-7006|
|Principal Investigator:||Valdemar Grill, M.D.||St. Olavs Hospital, NTNU|