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Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia (TRIGPP)

Primary Purpose

Hypertriglyceridemia, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Postprandial test
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertriglyceridemia focused on measuring Postprandial test, Metabolic syndrime, HTG

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pitié Salpetriere Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Isolated HTG without metabolic syndrome

HTG with metabolic syndrome

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Apo B48 peak plasma concentration
Apo B48 (g/L) peak plasma concentration (Cmax)

Full Information

First Posted
December 21, 2015
Last Updated
September 28, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02898142
Brief Title
Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia
Acronym
TRIGPP
Official Title
Evaluation of Intestinal and Hepatic Parts in Fasting Postprandial Hypertriglyceridemia in Patients With or Without Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia, Metabolic Syndrome
Keywords
Postprandial test, Metabolic syndrime, HTG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isolated HTG without metabolic syndrome
Arm Type
Experimental
Arm 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.
Arm Title
HTG with metabolic syndrome
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Postprandial test
Intervention 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. This post prandial test is the same in the two study groups.
Primary Outcome Measure Information:
Title
Apo B48 plasma concentration
Description
Area under the Apo B48 (g/L) plasma concentration (g/L) measured every hour for 6 hours versus time curve (AUC).
Time Frame
every hour for 6 hours (day of sampling after postprandial test)
Secondary Outcome Measure Information:
Title
Apo B48 peak plasma concentration
Description
Apo B48 (g/L) peak plasma concentration (Cmax)
Time Frame
the highest level of Apo B48 during the test of 6 hours (day of sampling after postprandial test)
Other Pre-specified Outcome Measures:
Title
Apo B100 plasma concentration
Description
Area under the Apo B100 (g/L) plasma concentration (g/L) measured every hour for 6 hours versus time curve (AUC).
Time Frame
every hour for 6 hours (day of sampling after postprandial test)
Title
Apo B100 peak plasma concentration
Description
Apo B100 (g/L) peak plasma concentration (Cmax)
Time Frame
the highest level of Apo B100 during the test of 6 hours
Title
Triglycerides peak plasma concentration
Description
Triglycerides (g/L) peak plasma concentration (Cmax)
Time Frame
The highest level of triglycerides during the test of 6 hours
Title
Glycemia plasma concentration
Description
Area under the glycemia plasma concentration (mmol/L) measured every hour for 6 hours versus time curve (AUC)
Time Frame
every hour for 6 hours
Title
Glycemia peak plasma concentration
Description
Glycemia (mmol/L/L) peak plasma concentration (Cmax) during the postprandial test
Time Frame
the highest level of glycemia during the 6-hours postprandial test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Giral, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitié Salpetriere Hospital
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25332284
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.
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Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia

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