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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Dietary Supplement: Intralipid +/- Omegaven | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Intralipid with/without Omegaven
Lipid infusion with/without marine n-3 fatty acids
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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:
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- insulin sensitivity [ Time Frame: 4 hours ]
- 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 ]

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Norway | |
Department of Medicine, Division of Endocrinology, St. Olavs Hospital | |
Trondheim, Norway, N-7006 |
Principal Investigator: | Valdemar Grill, M.D. | St. Olavs Hospital, NTNU |
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 |