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n-3 Fatty Acid Infusion and Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00829569
Recruitment Status : Completed
First Posted : January 27, 2009
Last Update Posted : November 4, 2011
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Norwegian Foundation for Health and Rehabilitation
Novo Nordisk A/S
Norwegian Diabetes Association
Information provided by (Responsible Party):
St. Olavs Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : January 2004
Actual Primary Completion Date : May 2004
Actual Study Completion Date : October 2008

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U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. n-3 fatty acid distribution [ Time Frame: 4 hours ]
  2. insulin secretion [ Time Frame: 4 hours ]
  3. energy metabolism [ Time Frame: 4 hours ]
  4. oxidative stress [ Time Frame: 4 hours ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 A/S
Norwegian Diabetes Association
Investigators
Principal Investigator: Valdemar Grill, M.D. St. Olavs Hospital, NTNU
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00829569     History of Changes
Other Study ID Numbers: 4.2003.169
03-14463 ( Other Identifier: SLV )
15759 ( Other Identifier: The Data Inspectorate )
03/05008 ( Other Identifier: Biobank )
First Posted: January 27, 2009    Key Record Dates
Last Update Posted: November 4, 2011
Last Verified: November 2011

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
 Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions