Type 2 DiabetesNCT00829569
n-3 Fatty Acid Infusion and Type 2 Diabetes
A study testing Intralipid +/- Omegaven in people with Type 2 Diabetes, run by St. Olavs Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Intralipid +/- Omegaven
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- allergy to soya, fish or egg
- pregnancy or lactation
- smoking
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Medicine, Division of Endocrinology, St. Olavs Hospital
Trondheim, N-7006
About this study
Official title: Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Intralipid +/- Omegaven
- Keywords
- Intralipid, Omegaven, fish oil, hyperinsulinemic isoglycemic clamps, C-peptide glucagon test, indirect calorimetry, F2-isoprostanes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid +/- OmegavenDietary supplement
Also called Fresenius Kabi, ATC main group B05B A 02, Intralipid Vnr 42 79 55, Omegaven Vnr 55 25 54
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).
| Study group | Role | What they receive |
|---|---|---|
| Intralipid with/without Omegaven | Experimental | Lipid infusion with/without marine n-3 fatty acids Receives: Dietary Supplement: Intralipid +/- Omegaven |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin sensitivity
Measured: 4 hours
Secondary outcomes (4)
n-3 fatty acid distribution
Measured: 4 hours
insulin secretion
Measured: 4 hours
energy metabolism
Measured: 4 hours
oxidative stress
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startJan 2004
- Primary completionMay 2004
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Norwegian Foundation for Health and Rehabilitation, Novo Nordisk A/S, Norwegian Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Valdemar Grill, M.D., Principal investigator, St. Olavs Hospital, NTNU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829569
- Sponsor's protocol ID
- 4.2003.169
- Other IDs
- 03-14463, 15759, 03/05008
- Status last verified
- Nov 2011
- First submitted
- 26 Jan 2009
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19716144
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Marine n-3 Fatty Acid Infusion on Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00829569
- Acronym / sponsor ID
- 4.2003.169
- Conditions
- Type 2 Diabetes
- Keywords
- Intralipid, Omegaven, fish oil, hyperinsulinemic isoglycemic clamps, C-peptide glucagon test, indirect calorimetry, F2-isoprostanes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Norwegian Foundation for Health and Rehabilitation, Novo Nordisk A/S, Norwegian Diabetes Association
- Study start
- Jan 2004
- Primary completion
- May 2004 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intralipid with/without Omegaven | Experimental | Dietary Supplement: Intralipid +/- OmegavenLipid infusion with/without marine n-3 fatty acids |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralipid +/- OmegavenAlso: Fresenius Kabi, ATC main group B05B A 02, Intralipid Vnr 42 79 55, Omegaven Vnr 55 25 54Intralipid®: 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). | Dietary supplement | Intralipid with/without Omegaven |
Primary outcome
insulin sensitivity
Time frame: 4 hours
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Results publication: PubMed 19716144Mostad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valdemar Grill, M.D. principal investigator
St. Olavs Hospital, NTNU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralipid +/- Omegaven in people with Type 2 Diabetes, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insulin sensitivity (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.