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Trial record 14 of 808 for:    APOB

Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia (TRIGPP)

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ClinicalTrials.gov Identifier: NCT02898142
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Metabolic Syndrome Other: Postprandial test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Intestinal and Hepatic Parts in Fasting Postprandial Hypertriglyceridemia in Patients With or Without Metabolic Syndrome
Study Start Date : February 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Isolated HTG without metabolic syndrome
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
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.

Experimental: HTG with metabolic syndrome
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
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 Measures :
  1. Apo B48 plasma concentration [ Time Frame: every hour for 6 hours (day of sampling after postprandial test) ]
    Area under the Apo B48 (g/L) plasma concentration (g/L) measured every hour for 6 hours versus time curve (AUC).


Secondary Outcome Measures :
  1. Apo B48 peak plasma concentration [ Time Frame: the highest level of Apo B48 during the test of 6 hours (day of sampling after postprandial test) ]
    Apo B48 (g/L) peak plasma concentration (Cmax)


Other Outcome Measures:
  1. Apo B100 plasma concentration [ Time Frame: every hour for 6 hours (day of sampling after postprandial test) ]
    Area under the Apo B100 (g/L) plasma concentration (g/L) measured every hour for 6 hours versus time curve (AUC).

  2. Apo B100 peak plasma concentration [ Time Frame: the highest level of Apo B100 during the test of 6 hours ]
    Apo B100 (g/L) peak plasma concentration (Cmax)

  3. Triglycerides peak plasma concentration [ Time Frame: The highest level of triglycerides during the test of 6 hours ]
    Triglycerides (g/L) peak plasma concentration (Cmax)

  4. Glycemia plasma concentration [ Time Frame: every hour for 6 hours ]
    Area under the glycemia plasma concentration (mmol/L) measured every hour for 6 hours versus time curve (AUC)

  5. Glycemia peak plasma concentration [ Time Frame: the highest level of glycemia during the 6-hours postprandial test ]
    Glycemia (mmol/L/L) peak plasma concentration (Cmax) during the postprandial test



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898142


Locations
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France
Pitié Salpetriere Hospital
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Philippe Giral, MD Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02898142     History of Changes
Other Study ID Numbers: P111003
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Postprandial test
Metabolic syndrime
HTG
Additional relevant MeSH terms:
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Metabolic Syndrome
Hypertriglyceridemia
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders