Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2004-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Intralipid with/without Omegaven
Lipid infusion with/without marine n-3 fatty acids
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HbA1c 5,5 - 8,5 %
* Blood pressure ≤ 170 mm Hg systolic and/or ≤ 105 mm Hg diastolic
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
Norwegian Foundation for Health and Rehabilitation
OTHER
Novo Nordisk A/S
INDUSTRY
Norwegian Diabetes Association
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Valdemar Grill, M.D.
Role: PRINCIPAL_INVESTIGATOR
St. Olavs Hospital, NTNU
Locations
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Department of Medicine, Division of Endocrinology, St. Olavs Hospital
Trondheim, , Norway
Countries
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References
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Mostad IL, Bjerve KS, Basu S, Sutton P, Frayn KN, Grill V. Addition of n-3 fatty acids to a 4-hour lipid infusion does not affect insulin sensitivity, insulin secretion, or markers of oxidative stress in subjects with type 2 diabetes mellitus. Metabolism. 2009 Dec;58(12):1753-61. doi: 10.1016/j.metabol.2009.06.003. Epub 2009 Aug 27.
Other Identifiers
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03-14463
Identifier Type: OTHER
Identifier Source: secondary_id
15759
Identifier Type: OTHER
Identifier Source: secondary_id
03/05008
Identifier Type: OTHER
Identifier Source: secondary_id
4.2003.169
Identifier Type: -
Identifier Source: org_study_id