n-3 Fatty Acid Infusion and Type 2 Diabetes

Sponsor

St. Olavs Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00829569

Collaborator

Norwegian University of Science and Technology (Other), Norwegian Foundation for Health and Rehabilitation (Other), Novo Nordisk A/S (Industry), Norwegian Diabetes Association (Other)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Dietary Supplement: Intralipid +/- Omegaven	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes

Study Start Date :

Jan 1, 2004

Actual Primary Completion Date :

May 1, 2004

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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). Other Names: Fresenius Kabi, ATC main group B05B A 02 Intralipid Vnr 42 79 55 Omegaven Vnr 55 25 54

Arm

Intervention/Treatment

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).

Other Names:

Fresenius Kabi, ATC main group B05B A 02

Intralipid Vnr 42 79 55

Omegaven Vnr 55 25 54

Outcome Measures

Primary Outcome Measures

insulin sensitivity [4 hours]

Secondary Outcome Measures

n-3 fatty acid distribution [4 hours]
insulin secretion [4 hours]
energy metabolism [4 hours]
oxidative stress [4 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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