Type 2 DiabetesDBB48NCT01449773
Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes
A study testing n-3 PUFAs in people with Type 2 Diabetes, run by Laval University at 1 site in Canada.
Trial summary
The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients with type 2 diabetes are now thought to be attributable to elevated intestinal production and reduced clearance. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- n-3 PUFAs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Jan 2013
- 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 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 55 years,
- plasma TG levels above the 50th percentile for age,
- non-smoker,
- BMI between 25.0 and 40.0 kg/m2,
- stable body weight for at least 6 months prior to the study baseline,
- HbA1c between 6.5 and 8.5%,
- baseline fasting plasma glucose < 15.0 mmol/L
- patients with de novo type 2 diabetes not taking oral hypoglycemic agents -- - or patients having received stable doses of metformin for at least 3 months before randomization.
Who cannot join
- extreme dyslipidemias such as familial hypercholesterolemia,
- patients with secondary form of diabetes or acute metabolic diabetic complications,
- patients having received or being treated with insulin or a thiazolidinedione within the past 6 months,
- subjects having CVD (CHD, cerebrovascular disease or peripheral arterial disease)
- subjects taking medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents,
- significant alcohol intake
Trial locations and contacts
1 site in 1 country.
About this study
The overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients with type 2 diabetes are now thought to be attributable to elevated intestinal production and reduced clearance. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia. However, the investigators understanding of the physiological changes that occur with n-3 PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the intestinal production of TRLs and the expression of genes regulating intestinal lipid absorption and chylomicron synthesis have not yet been examined in humans. The general objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:
- reduce TRL apoB-48 production rate and increase fractional catabolic rate of these lipoproteins,
- decrease the expression of genes that regulate intestinal lipid absorption and synthesis as well as synthesis of apoB-48-containing lipoproteins,
- decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.
- Conditions
- Type 2 Diabetes
- Being tested
- n-3 PUFAs, Placebo
- 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.
n-3 PUFAsDietary supplement
5 capsules/day in order to provide 3 g/day of n-3 PUFAs.
PlaceboDietary supplement
5 capsules/day containing corn and soybean oil
| Study group | Role | What they receive |
|---|---|---|
| n-3 PUFAs | Experimental | Not described Receives: Dietary Supplement: n-3 PUFAs |
| Corn and soybean oil pill | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the in vivo kinetics of intestinally derived apoB-48-containing lipoproteins between the two 8-week interventions
Measured: At the end of the two 8-week interventions
Secondary outcomes (2)
Change in the expression of genes that regulate intestinal lipid absorption (NPC1L1, ABCG5/8, FABP, SREBP-1c) and synthesis (DGAT, ACAT2, HMG CoA reductase) as well as synthesis of apoB-48-containing lipoproteins (MTP)between the two 8-week interventions
Measured: At the end of the two 8-week interventions
Change in the plasma surrogates of cholesterol absorption (campesterol, beta-sitosterol) and synthesis (lathosterol) between the two 8-week interventions
Measured: At the end of the two 8-week interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionJan 2013
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD, PhD, FRCP, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449773
- Sponsor's protocol ID
- INAF-117.05.01
- Acronym
- DBB48
- Status last verified
- Feb 2013
- First submitted
- 6 Oct 2011
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Labonte ME, Couture P, Tremblay AJ, Hogue JC, Lemelin V, Lamarche B. Eicosapentaenoic and docosahexaenoic acid supplementation and inflammatory gene expression in the duodenum of obese patients with type 2 diabetes. Nutr J. 2013 Jul 15;12:98. doi: 10.1186/1475-2891-12-98.
PubMed 23855973
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of N-3 Polyunsaturated Fatty Acids On Chylomicron Secretion And Expression Of Genes That Regulate Intestinal Lipid Metabolism In Men With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01449773
- Acronym / sponsor ID
- DBB48 / INAF-117.05.01
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 10 Oct 2011 (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 overaccumulation of apoB-48-containing lipoproteins of intestinal origin seen in patients with type 2 diabetes are now thought to be attributable to elevated intestinal production and reduced clearance. Substantial evidence exists indicating that elevated plasma levels of these lipoproteins are associated with increased cardiovascular disease risk. Therefore, reduction of atherogenic plasma triglyceride-rich lipoproteins (TRL) levels of intestinal origin appears to be crucial to improve CVD risk associated with type 2 diabetes. In this regard, n-3 PUFAs have been shown to exert beneficial effects on diabetic dyslipidemia. However, the investigators understanding of the physiological changes that occur with n-3 PUFA supplementation is suboptimal, thereby limiting the investigators appreciation of its impact on CVD risk associated with type 2 diabetes. The effects of n-3 PUFAs on the intestinal production of TRLs and the expression of genes regulating intestinal lipid absorption and chylomicron synthesis have not yet been examined in humans. The general objective of the proposed research is to investigate the mechanisms by which n-3 PUFAs beneficially modify intestinal lipoprotein metabolism in patients with type 2 diabetes. The investigators hypothesize that n-3 PUFA supplementation in men with type 2 diabetes will:
- reduce TRL apoB-48 production rate and increase fractional catabolic rate of these lipoproteins,
- decrease the expression of genes that regulate intestinal lipid absorption and synthesis as well as synthesis of apoB-48-containing lipoproteins,
- decrease both plasma surrogates of cholesterol absorption and cholesterol synthesis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| n-3 PUFAs | Experimental | Dietary Supplement: n-3 PUFAs |
| Corn and soybean oil pill | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- age between 18 and 55 years,
- plasma TG levels above the 50th percentile for age,
- non-smoker,
- BMI between 25.0 and 40.0 kg/m2,
- stable body weight for at least 6 months prior to the study baseline,
Key exclusion criteria (6 listed)
- extreme dyslipidemias such as familial hypercholesterolemia,
- patients with secondary form of diabetes or acute metabolic diabetic complications,
- patients having received or being treated with insulin or a thiazolidinedione within the past 6 months,
- subjects having CVD (CHD, cerebrovascular disease or peripheral arterial disease)
- subjects taking medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents,
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 |
|---|---|---|
| n-3 PUFAs5 capsules/day in order to provide 3 g/day of n-3 PUFAs. | Dietary supplement | n-3 PUFAs |
| Placebo5 capsules/day containing corn and soybean oil | Dietary supplement | Corn and soybean oil pill |
Primary outcome
Change in the in vivo kinetics of intestinally derived apoB-48-containing lipoproteins between the two 8-week interventions
Time frame: At the end of the two 8-week interventions
2 secondary outcomes
Change in the expression of genes that regulate intestinal lipid absorption (NPC1L1, ABCG5/8, FABP, SREBP-1c) and synthesis (DGAT, ACAT2, HMG CoA reductase) as well as synthesis of apoB-48-containing lipoproteins (MTP)between the two 8-week interventions
Time frame: At the end of the two 8-week interventions
Change in the plasma surrogates of cholesterol absorption (campesterol, beta-sitosterol) and synthesis (lathosterol) between the two 8-week interventions
Time frame: At the end of the two 8-week interventions
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 Mar 2013.
- Derived from this study: PubMed 23855973Labonte ME, Couture P, Tremblay AJ, Hogue JC, Lemelin V, Lamarche B. Eicosapentaenoic and docosahexaenoic acid supplementation and inflammatory gene expression in the duodenum of obese patients with type 2 diabetes. Nutr J. 2013 Jul 15;12:98. doi: 10.1186/1475-2891-12-98.
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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.
Patrick Couture, MD, PhD, FRCP 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 study testing n-3 PUFAs in people with 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 8 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 4 Mar 2013. 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. Some participants in this study may receive a placebo. 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?
Change in the in vivo kinetics of intestinally derived apoB-48-containing lipoproteins between the two 8-week interventions (time frame: At the end of the two 8-week interventions). 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 NCT01449773, 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 Mar 2013.