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n-3 Fatty Acid Infusion and Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Norwegian Foundation for Health and Rehabilitation
Novo Nordisk
Norwegian Diabetes Association
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00829569
First received: January 26, 2009
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes
 Dietary Supplement: Intralipid +/- Omegaven

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • n-3 fatty acid distribution [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • insulin secretion [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • energy metabolism [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • oxidative stress [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: January 2004
Study Completion Date: October 2008
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829569

Locations
Norway
Department of Medicine, Division of Endocrinology, St. Olavs Hospital
Trondheim, Norway, N-7006
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
Norwegian Foundation for Health and Rehabilitation
Novo Nordisk
Norwegian Diabetes Association
Investigators
Principal Investigator: Valdemar Grill, M.D. St. Olavs Hospital, NTNU
  More Information

Publications:

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00829569     History of Changes
Other Study ID Numbers: 4.2003.169, 03-14463, 15759, 03/05008
Study First Received: January 26, 2009
Last Updated: November 3, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:
Intralipid
Omegaven
fish oil
hyperinsulinemic isoglycemic clamps
 C-peptide glucagon test
indirect calorimetry
F2-isoprostanes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 17, 2013