Clinical trial NCT02898142: Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia
Official title: Evaluation of Intestinal and Hepatic Parts in Fasting Postprandial Hypertriglyceridemia in Patients With or Without Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertriglyceridemia
Metabolic Syndrome
Keywords: Postprandial test
Metabolic syndrime
HTG
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility criteria: Inclusion criteria :

1. Patient who provided his consent in writing before the completion of any procedure related to the Protocol
2. Patient affiliated to the French social security system or to another similar insurance
3. Men and women aged from 18 years to 75 years
4. Patient of Department of Endocrinology-Metabolism and hospitalized for a medical checkup
5. Fasting hypertriglyceridemia \>1.5 g / L
6. No lipid-lowering treatment or omega 3
7. Patients with an untreated systolic blood pressure \<130mmHg and diastolic \<85mmHg
8. Stable weight (variation less than 5 kg in the month before inclusion)

Inclusion in the metabolic syndrome group if :

* 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"

Exclusion criteria :

1. Diabetic Patient
2. Any recent changes (less than one month) of any treatment
3. Patient participating in another clinical study

Primary outcomes:
measure: Apo B48 plasma concentration
timeFrame: every hour for 6 hours (day of sampling after postprandial test)
Secondary outcomes:
measure: Apo B48 peak plasma concentration
timeFrame: the highest level of Apo B48 during the test of 6 hours (day of sampling after postprandial test)
Other outcomes:
measure: Apo B100 plasma concentration
timeFrame: every hour for 6 hours (day of sampling after postprandial test)
measure: Apo B100 peak plasma concentration
timeFrame: the highest level of Apo B100 during the test of 6 hours
measure: Triglycerides peak plasma concentration
timeFrame: The highest level of triglycerides during the test of 6 hours
measure: Glycemia plasma concentration
timeFrame: every hour for 6 hours
measure: Glycemia peak plasma concentration
timeFrame: the highest level of glycemia during the 6-hours postprandial test
Locations:
city: Paris
country: France
facility: Pitié Salpetriere Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Giral, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.