Insulin ResistancePhase 2NCT00400036
Dietary Fish Protein in Subjects With Insulin Resistance
A Phase 2 study testing Cod protein NCEP-diet in people with Insulin Resistance and Type 2 Diabetes, run by Laval University at 1 site in Canada.
Trial summary
The objective of our research project is to determine the effects of fish protein, present in fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of action on glucose metabolism. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes
- What is being tested?
- Cod protein NCEP-diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2004to Dec 2005
- Phase
- Phase 2
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- overweight or obese (BMI between 25 and 40 kg /m2)
- waist circumference above 88 cm for women and 102 cm for men
- fasting plasma insulin above 90 pmol/L
- fasting plasma glucose below 7.0 mmol/L and 2-h plasma glucose below 11.1 mmol/L
Who cannot join
- Individuals with diagnosed diabetes or any chronic, metabolic or acute disease
- Individuals who had a major surgery within the last 3 months
- Individuals who had a significant weight loss (±10%) within the last 6 months
- Individuals taking any medication known to affect lipid or glucose metabolism
- Subjects with dietary incompatibility with fish consumption (allergy, intolerance or dislike) and/or calcium supplementation
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein
The objective of our research project is to determine the effects of fish protein, present in fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of action on glucose metabolism. Our hypothesis is that fish protein improves insulin sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary defect in insulin signaling in overweight and insulin-resistant subjects.
Read the detailed description
Recent data show that cod protein prevents the development of insulin resistance in rats. Dietary fish protein may also enhance insulin sensitivity in overweight insulin-resistant subjects by improving a primary defect in insulin signaling to PI 3-kinase, leading to reduced activation of the downstream effectors Akt and PKC. To determine whether this is the case, we will study the effects of fish protein on insulin sensitivity in humans, and how it improves the ability of muscles to use glucose. Such studies will help to advise individuals with insulin resistance or type 2 diabetes about eating fish.
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Being tested
- Cod protein NCEP-diet
- Keywords
- cod protein, insulin sensitivity, plasma lipids, glucose tolerance, plasma inflammatory markers, skeletal muscle insulin signaling, type 2 diabetes, humans
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cod protein NCEP-dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity at 4 weeks
Insulin signaling in skeletal muscle at 4 weeks
Secondary outcomes (3)
plasma lipids and lipoproteins at 4 weeks
plasma inflammatory markers at 4 weeks
glucose tolerance at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startFeb 2004
- Study completionDec 2005
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 Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Investigators
- Helene Jacques, PhD, Principal investigator, Laval UniversityAndre Marette, PhD, Principal investigator, Laval UniversityStanley J Weisnagel, MD / FRCPC, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400036
- Sponsor's protocol ID
- MOP-64443
- Status last verified
- Nov 2006
- First submitted
- 14 Nov 2006
- Last updated
- 16 Nov 2006
- Results posted
- No
Publications
Ouellet V, Marois J, Weisnagel SJ, Jacques H. Dietary cod protein improves insulin sensitivity in insulin-resistant men and women: a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2816-21. doi: 10.2337/dc07-0273. Epub 2007 Aug 6.
PubMed 17682120
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein
- ClinicalTrials.gov ID
- NCT00400036
- Acronym / sponsor ID
- MOP-64443
- Conditions
- Insulin Resistance, Type 2 Diabetes
- Keywords
- cod protein, insulin sensitivity, plasma lipids, glucose tolerance, plasma inflammatory markers, skeletal muscle insulin signaling, type 2 diabetes, humans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Feb 2004
- Study completion
- Dec 2005
- First posted
- 16 Nov 2006 (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 objective of our research project is to determine the effects of fish protein, present in fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of action on glucose metabolism. Our hypothesis is that fish protein improves insulin sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary defect in insulin signaling in overweight and insulin-resistant subjects.
Detailed description
Recent data show that cod protein prevents the development of insulin resistance in rats. Dietary fish protein may also enhance insulin sensitivity in overweight insulin-resistant subjects by improving a primary defect in insulin signaling to PI 3-kinase, leading to reduced activation of the downstream effectors Akt and PKC. To determine whether this is the case, we will study the effects of fish protein on insulin sensitivity in humans, and how it improves the ability of muscles to use glucose. Such studies will help to advise individuals with insulin resistance or type 2 diabetes about eating fish.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- overweight or obese (BMI between 25 and 40 kg /m2)
- waist circumference above 88 cm for women and 102 cm for men
- fasting plasma insulin above 90 pmol/L
- fasting plasma glucose below 7.0 mmol/L and 2-h plasma glucose below 11.1 mmol/L
Key exclusion criteria (6 listed)
- Individuals with diagnosed diabetes or any chronic, metabolic or acute disease
- Individuals who had a major surgery within the last 3 months
- Individuals who had a significant weight loss (±10%) within the last 6 months
- Individuals taking any medication known to affect lipid or glucose metabolism
- Subjects with dietary incompatibility with fish consumption (allergy, intolerance or dislike) and/or calcium supplementation
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 |
|---|---|---|
| Cod protein NCEP-diet | Behavioural | – |
Primary outcome
Insulin sensitivity at 4 weeks
Insulin signaling in skeletal muscle at 4 weeks
3 secondary outcomes
plasma lipids and lipoproteins at 4 weeks
plasma inflammatory markers at 4 weeks
glucose tolerance at 4 weeks
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 16 Nov 2006.
- Derived from this study: PubMed 17682120Ouellet V, Marois J, Weisnagel SJ, Jacques H. Dietary cod protein improves insulin sensitivity in insulin-resistant men and women: a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2816-21. doi: 10.2337/dc07-0273. Epub 2007 Aug 6.
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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.
Helene Jacques, PhD principal investigator
Laval University
Andre Marette, PhD principal investigator
Laval University
Stanley J Weisnagel, MD / FRCPC principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cod protein NCEP-diet in people with Insulin Resistance and Type 2 Diabetes, run by Laval University at 1 site in Canada.
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 4 inclusion and 6 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 16 Nov 2006. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 at 4 weeks. The study lists 2 primary outcomes in all. 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 NCT00400036, 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 16 Nov 2006.