NCT00829569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
Last Updated

November 4, 2011

Status Verified

November 1, 2011

Enrollment Period

4 months

First QC Date

January 26, 2009

Last Update Submit

November 3, 2011

Conditions

Type 2 Diabetes

Keywords

IntralipidOmegavenfish oilhyperinsulinemic isoglycemic clampsC-peptide glucagon testindirect calorimetryF2-isoprostanes

Outcome Measures

Primary Outcomes (1)

  • insulin sensitivity

    4 hours

Secondary Outcomes (4)

  • n-3 fatty acid distribution

    4 hours

  • insulin secretion

    4 hours

  • energy metabolism

    4 hours

  • oxidative stress

    4 hours

Study Arms (1)

Intralipid with/without Omegaven

EXPERIMENTAL

Lipid infusion with/without marine n-3 fatty acids

Dietary Supplement: Intralipid +/- Omegaven

Interventions

Intralipid +/- OmegavenDIETARY_SUPPLEMENT

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).

Also known as: Fresenius Kabi, ATC main group B05B A 02, Intralipid Vnr 42 79 55, Omegaven Vnr 55 25 54
Intralipid with/without Omegaven

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Endocrinology, St. Olavs Hospital

Trondheim, N-7006, Norway

Location

Related 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. 2009 Dec;58(12):1753-61. doi: 10.1016/j.metabol.2009.06.003. Epub 2009 Aug 27.

    PMID: 19716144RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Valdemar Grill, M.D.

    St. Olavs Hospital, NTNU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

January 1, 2004

Primary Completion

May 1, 2004

Study Completion

October 1, 2008

Last Updated

November 4, 2011

Record last verified: 2011-11

Locations

NO(1)