HypertriglyceridemiaTRIGPPNCT02898142
Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia
A study testing Postprandial test in people with Hypertriglyceridemia and Metabolic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of intestinal triglyceride rich lipoproteins in patients with isolated fasting hypertriglyceridemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertriglyceridemia, Metabolic Syndrome
- What is being tested?
- Postprandial test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Sep 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who provided his consent in writing before the completion of any procedure related to the Protocol
- Patient affiliated to the French social security system or to another similar insurance
- Men and women aged from 18 years to 75 years
- Patient of Department of Endocrinology-Metabolism and hospitalized for a medical checkup
- Fasting hypertriglyceridemia >1.5 g / L
- No lipid-lowering treatment or omega 3
Show all 11Show fewer
- Patients with an untreated systolic blood pressure <130mmHg and diastolic <85mmHg
- Stable weight (variation less than 5 kg in the month before inclusion)
- Fasting glucose > 5.6 mmol / L but <7.0 mmol / L and
- Waist perimeter >94 cm in men and >80cm in women.
- Inclusion in isolated hypertriglyceridemia group: patients not having the criteria of the group "metabolic syndrome"
Who cannot join
- Diabetic Patient
- Any recent changes (less than one month) of any treatment
- Patient participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intestinal and Hepatic Parts in Fasting Postprandial Hypertriglyceridemia in Patients With or Without Metabolic Syndrome
Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of intestinal triglyceride rich lipoproteins in patients with isolated fasting hypertriglyceridemia.
The objective of this study is to compare the serum apoB48 rate after a standardized load test, among patients with isolated hypertriglyceridemia and patients with metabolic syndrome.
Read the detailed description
Two major studies in 2007 showed that the occurrence of myocardial infarction and death was more frequent in subjects with the highest "non-fasting" triglycerides level. This is an important point that supports the hypothesis that the development of atheromatous lesions also depends on "remnant" of triglyceride-rich lipoproteins (TRL) products such as chylomicrons in the intestine. The elevation of triglycerides in postprandial period depends on the intestinal production of TRL that can be excessively increased as has been shown in diabetes. Accordingly, it is necessary to distinguish between hepatic and intestinal production of TRL in hypertriglyceridemic patients particularly during postprandial period. TRL contain a single molecule of apolipoprotein B (apoB), apoB100 when produced by the liver or apoB-48 when they are produced by the gut. It is well known that apo B100 is the lipoprotein of the VLDL which is increased in hypertriglyceridemia. But preliminary works showed that fasting concentrations of apoB48 were correlated with triglycerides in some hypertriglyceridemic patients. These results suggest an intestinal part in fasting triglycerides levels. It therefore appears that the liver and intestine contribute to hypertriglyceridemia, but the intestinal part is not established particularly in isolated hypertriglyceridemia. The detection of abnormalities in the production of LRT would consider intestinal bowel as a target organ for the initiation of specific lipid-lowering therapy.
- Conditions
- Hypertriglyceridemia, Metabolic Syndrome
- Being tested
- Postprandial test
- Keywords
- Postprandial test, Metabolic syndrime, HTG
- Medical subject headings
- Hypertriglyceridemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postprandial testOther
Postprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. This post prandial test is the same in the two study groups.
| Study group | Role | What they receive |
|---|---|---|
| Isolated HTG without metabolic syndrome | Experimental | Postprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. Receives: Other: Postprandial test |
| HTG with metabolic syndrome | Experimental | Postprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. Receives: Other: Postprandial test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apo B48 plasma concentration
Area under the Apo B48 (g/L) plasma concentration (g/L) measured every hour for 6 hours versus time curve (AUC).
Measured: every hour for 6 hours (day of sampling after postprandial test)
Secondary outcomes (1)
Apo B48 peak plasma concentration
Apo B48 (g/L) peak plasma concentration (Cmax)
Measured: the highest level of Apo B48 during the test of 6 hours (day of sampling after postprandial test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionSep 2015
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 HypertriglyceridemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Giral, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898142
- Sponsor's protocol ID
- P111003
- Acronym
- TRIGPP
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Giral P, Simon D, Chapman MJ. Letter by Giral et al regarding article, "lipoprotein(a) concentrations, rosuvastatin therapy, and residual vascular risk: an analysis from the JUPITER trial (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin)". Circulation. 2014 Oct 21;130(17):e151. doi: 10.1161/CIRCULATIONAHA.114.009590. No abstract available.
PubMed 25332284
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intestinal and Hepatic Parts in Fasting Postprandial Hypertriglyceridemia in Patients With or Without Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02898142
- Acronym / sponsor ID
- TRIGPP / P111003
- Conditions
- Hypertriglyceridemia, Metabolic Syndrome
- Keywords
- Postprandial test, Metabolic syndrime, HTG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Sep 2016 (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.
Fasting and postprandial hypertriglyceridemia (HTG) depends on increased production of intestinal triglyceride rich lipoproteins in patients with isolated fasting hypertriglyceridemia.
The objective of this study is to compare the serum apoB48 rate after a standardized load test, among patients with isolated hypertriglyceridemia and patients with metabolic syndrome.
Detailed description
Two major studies in 2007 showed that the occurrence of myocardial infarction and death was more frequent in subjects with the highest "non-fasting" triglycerides level. This is an important point that supports the hypothesis that the development of atheromatous lesions also depends on "remnant" of triglyceride-rich lipoproteins (TRL) products such as chylomicrons in the intestine. The elevation of triglycerides in postprandial period depends on the intestinal production of TRL that can be excessively increased as has been shown in diabetes. Accordingly, it is necessary to distinguish between hepatic and intestinal production of TRL in hypertriglyceridemic patients particularly during postprandial period. TRL contain a single molecule of apolipoprotein B (apoB), apoB100 when produced by the liver or apoB-48 when they are produced by the gut. It is well known that apo B100 is the lipoprotein of the VLDL which is increased in hypertriglyceridemia. But preliminary works showed that fasting concentrations of apoB48 were correlated with triglycerides in some hypertriglyceridemic patients. These results suggest an intestinal part in fasting triglycerides levels. It therefore appears that the liver and intestine contribute to hypertriglyceridemia, but the intestinal part is not established particularly in isolated hypertriglyceridemia. The detection of abnormalities in the production of LRT would consider intestinal bowel as a target organ for the initiation of specific lipid-lowering therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isolated HTG without metabolic syndrome | Experimental | Other: Postprandial testPostprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. |
| HTG with metabolic syndrome | Experimental | Other: Postprandial testPostprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient who provided his consent in writing before the completion of any procedure related to the Protocol
- Patient affiliated to the French social security system or to another similar insurance
- Men and women aged from 18 years to 75 years
- Patient of Department of Endocrinology-Metabolism and hospitalized for a medical checkup
- Fasting hypertriglyceridemia >1.5 g / L
Key exclusion criteria (3 listed)
- Diabetic Patient
- Any recent changes (less than one month) of any treatment
- Patient participating in another clinical study
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 |
|---|---|---|
| Postprandial testPostprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. This post prandial test is the same in the two study groups. | Other | HTG with metabolic syndrome, Isolated HTG without metabolic syndrome |
Primary outcome
Apo B48 plasma concentration
Time frame: every hour for 6 hours (day of sampling after postprandial test)
Area under the Apo B48 (g/L) plasma concentration (g/L) measured every hour for 6 hours versus time curve (AUC).
1 secondary outcome
Apo B48 peak plasma concentration
Time frame: the highest level of Apo B48 during the test of 6 hours (day of sampling after postprandial test)
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 29 Sep 2016.
- Background: PubMed 25332284Giral P, Simon D, Chapman MJ. Letter by Giral et al regarding article, "lipoprotein(a) concentrations, rosuvastatin therapy, and residual vascular risk: an analysis from the JUPITER trial (justification for the use of statins in prevention: an intervention trial evaluating rosuvastatin)". Circulation. 2014 Oct 21;130(17):e151. doi: 10.1161/CIRCULATIONAHA.114.009590. No abstract available.
- Individual participant dataSharing planned: No
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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.
Philippe Giral, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postprandial test in people with Hypertriglyceridemia and Metabolic Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 11 inclusion and 3 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 29 Sep 2016. 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 France. 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?
Apo B48 plasma concentration (time frame: every hour for 6 hours (day of sampling after postprandial test)). 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 NCT02898142, 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 29 Sep 2016.