Clinical trial NCT00829569: n-3 Fatty Acid Infusion and Type 2 Diabetes
Official title: Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Intralipid
Omegaven
fish oil
hyperinsulinemic isoglycemic clamps
C-peptide glucagon test
indirect calorimetry
F2-isoprostanes
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Norwegian Foundation for Health and Rehabilitation
name: Novo Nordisk A/S
name: Norwegian Diabetes Association
First posted: 2009-01-27
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: insulin sensitivity
timeFrame: 4 hours
Secondary outcomes:
measure: n-3 fatty acid distribution
timeFrame: 4 hours
measure: insulin secretion
timeFrame: 4 hours
measure: energy metabolism
timeFrame: 4 hours
measure: oxidative stress
timeFrame: 4 hours
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Medicine, Division of Endocrinology, St. Olavs Hospital
Study officials:
affiliation: St. Olavs Hospital, NTNU
name: Valdemar Grill, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.