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

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 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

Resource links provided by NLM:

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:

insulin sensitivity [ Time Frame: 4 hours ]

Secondary Outcome Measures:

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


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

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 (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

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:

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.


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 )
Study First Received:	January 26, 2009
Last Updated:	November 3, 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

ClinicalTrials.gov processed this record on August 18, 2017

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