Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia

Metabolic Syndrome Clinical Trial

— TRIGPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898142
• Other study ID #: P111003
• Status: Completed
• Phase: N/A
• First received: December 21, 2015
• Last updated: September 28, 2016
• Start date: February 2012
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• Postprandial test
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.

Locations

Country	Name	City	State
France	Pitié Salpetriere Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apo B100 plasma concentration	Area under the Apo B100 (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)	No
Other	Apo B100 peak plasma concentration	Apo B100 (g/L) peak plasma concentration (Cmax)	the highest level of Apo B100 during the test of 6 hours	No
Other	Triglycerides peak plasma concentration	Triglycerides (g/L) peak plasma concentration (Cmax)	The highest level of triglycerides during the test of 6 hours	No
Other	Glycemia plasma concentration	Area under the glycemia plasma concentration (mmol/L) measured every hour for 6 hours versus time curve (AUC)	every hour for 6 hours	No
Other	Glycemia peak plasma concentration	Glycemia (mmol/L/L) peak plasma concentration (Cmax) during the postprandial test	the highest level of glycemia during the 6-hours postprandial test	No
Primary	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)	No
Secondary	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)	No