Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Intestinal and Hepatic Parts in Fasting Postprandial Hypertriglyceridemia in Patients With or Without Metabolic Syndrome

Conditions
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Hypertriglyceridemia, Metabolic Syndrome

Intervention / Treatment
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* Other: Postprandial test


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : 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 Patients with an untreated systolic blood pressure <130mmHg and diastolic <85mmHg 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 : Diabetic Patient Any recent changes (less than one month) of any treatment Patient participating in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isolated HTG without metabolic syndrome<br>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. | Other: Postprandial test<br>* 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.<br>|
| Experimental: HTG with metabolic syndrome<br>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. | Other: Postprandial test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | every hour for 6 hours (day of sampling after postprandial test) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apo B48 peak plasma concentration | Apo B48 (g/L) peak plasma concentration (Cmax) | the highest level of Apo B48 during the test of 6 hours (day of sampling after postprandial test) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postprandial test, Metabolic syndrime, HTG