Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia (TRIGPP)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Hypertriglyceridemia; Metabolic Syndrome

Treatments: Other: Postprandial test

Study type: Interventional

Funder types: Other

Identifiers

NCT02898142

P111003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Isolated HTG without metabolic syndrome

Experimental group

Description:

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.

Treatment:

Other: Postprandial test

HTG with metabolic syndrome

Experimental group

Description:

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.

Treatment:

Other: Postprandial test