n-3 Fatty Acid Infusion and Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829569
• Other study ID #: 4.2003.169
• Secondary ID: 03-144631575903/
• Status: Completed
• Phase: N/A
• First received: January 26, 2009
• Last updated: November 3, 2011
• Start date: January 2004
• Est. completion date: October 2008

Study information

• Verified date: November 2011
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2008
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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).

Locations

Country	Name	City	State
Norway	Department of Medicine, Division of Endocrinology, St. Olavs Hospital	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian Diabetes Association, Norwegian Foundation for Health and Rehabilitation, Norwegian University of Science and Technology, Novo Nordisk A/S

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity		4 hours	No
Secondary	n-3 fatty acid distribution		4 hours	No
Secondary	insulin secretion		4 hours	No
Secondary	energy metabolism		4 hours	No
Secondary	oxidative stress		4 hours	No