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 A/S
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 A/S
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
Soybean oil, phospholipid emulsion
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014