n-3 Fatty Acid Infusion and Type 2 Diabetes

Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in 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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Intralipid +/- Omegaven

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, N-7006
    • Department of Medicine, Division of Endocrinology, St. Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
insulin sensitivity	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
n-3 fatty acid distribution	4 hours
insulin secretion	4 hours
energy metabolism	4 hours
oxidative stress	4 hours

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Novo Nordisk A/S; Norwegian University of Science and Technology; Norwegian Foundation for Health and Rehabilitation; Norwegian Diabetes Association
• Investigators: Principal Investigator: Valdemar Grill, M.D., St. Olavs Hospital, NTNU

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): May 1, 2004
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: January 26, 2009
• First Submitted That Met QC Criteria: January 26, 2009
• First Posted (Estimate): January 27, 2009

Study Record Updates

• Last Update Posted (Estimate): November 4, 2011
• Last Update Submitted That Met QC Criteria: November 3, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Intralipid; indirect calorimetry; fish oil; Omegaven; hyperinsulinemic isoglycemic clamps; C-peptide glucagon test; F2-isoprostanes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: 4.2003.169; 03-14463 (Other Identifier: SLV); 15759 (Other Identifier: The Data Inspectorate); 03/05008 (Other Identifier: Biobank)