Genetic and Metabolism of Post-prandial HDL Particles

NCT03109067 | Completed

• 1 other identifier: C10-57
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Reverse cholesterol transport (RCT) pathway explains the anti-atherosclerosis role of HDL. Post prandial hypertriglyceridemia is highly predictive of atherosclerosis. TaqIB polymorphism in CETP gene plays a role on HDL particles, and might give a link between TaqIB polymorphism and the cardioprotective efficiency of HDL particles. Our main objective was to compare post-prandial HDL particles between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG), and their ability to mediate cellular cholesterol efflux, via SR-BI Scavenger Receptor class B type I (SR-BI) , ABCG1 and ABCA1 pathways.

Conditions

Healthy Volunteers

Keywords

Cholesterol, HDL, Postprandial Period, Polymorphism, Genetic

Outcome Measures

Primary Outcomes (1)

• Comparison of post-prandial HDL particles

  Compare post-prandial HDL particles area under curve (AUC) between patients having B2 allele carriers (genotype AA) to B1 allele carriers (genotype GG)

  before the meal (time = 0 hour) vs 2 hours after

Secondary Outcomes (5)

• Comparison of post-prandial HDL particles

  before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal

• Efflux capacity of postprandial HDL particles

  before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal

• Area under curves of triglyceridemia of apoB100 and apoB48

  before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal

• Plasmatic concentrations of apoB100

  before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal

• Correlation between the area under curve of triglyceridemia and the efflux capacity of HDL particles.

  before the meal (time = 0 hour), 2 hours, 4 hours, 6 hours and 8 hours after the meal

Study Arms (1)

Standardized meal

EXPERIMENTAL

Standardized meal for : 50 patients with a TaqIB AA polymorphism 50 patients with a TaqIB GG polymorphism

Other: Standardized meal

Interventions

Standardized meal OTHER

Blood samples performed at 5 different times : H0 before the meal, H2, H4, H6 and H8 after the meal

Standardized meal

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Affiliation to a national social security scheme
• Age between 18 and 60 years old
• Male subjects
• Participants harboring either a B2 (genotype AA) allele or a B1 (genotype GG) in TaqIB polymorphism of CETP gene
• Fasted plasmatic triglyceridemia \< 300 mg/dL
• Free prior and informed written consent given by the participant

You may not qualify if:

• Triglyceridemia \> 3 g/L
• Participants having other lipid-lowering agents than statin (fibrate, niacin, ezetimibe)
• Participants having a treatment (either systemic or local) which might interfere with the evaluation of study parameters.
• Excessive alcohol consumption, or any drug addiction. An excessive alcohol consumption is superior to 21 time 30 mL of alcohol or 120 mL of wine or 355 mL of beer.
• Regular smoker or smoking cessation within the last year
• Significant abnormality on the full blood count or plasmatic and urinary biochemistry analysis.
• Chronic or acute disease either life threatening or able to modify study results, including among others :
• Diabetes
• Renal diseases : nephrotic syndrome, chronic kidney failure and/or creatininemia \> 1.7 time the upper limit of normal (ULN).
• Hypothyroidism defined by thyroid-stimulating hormone \> 2x ULN
• Hepatobiliary disease or viral hepatitis B or C confirmed by transaminases \> 2x ULN or alkaline phosphatase \> 1.5x ULN or total bilirubinemia \> 1.5x ULN at screening.
• Known HIV
• Gastro-intestinal disorder or disease that might modify intestinal absorption, bariatric surgery.
• Participant who might interfere with the quality of the study or might compromise the study according to the investigator.
• Participants with uncontrolled hypertension defined by a systolic blood pressure \> 140 mmHg or a diastolic blood pressure \> 90 mmHg.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Centre d'Investigation Clinique Paris Est

Paris, 75013, France

Location

Related Publications (3)

• Lamaziere A, Rainteau D, Kc P, Humbert L, Gauliard E, Ichou F, Ponnaiah M, Bouby N, Salem JE, Mallet JM, Guerin M, Lesnik P. Distinct Postprandial Bile Acids Responses to a High-Calorie Diet in Men Volunteers Underscore Metabolically Healthy and Unhealthy Phenotypes. Nutrients. 2020 Nov 19;12(11):3545. doi: 10.3390/nu12113545.

  PMID: 33228154 BACKGROUND

• Motte AM, Gall JG, Salem JE, Dasque E, Lebot M, Frisdal E, Galier S, Villard EF, Bouaziz-Amar E, Lacorte JM, Charbit B, Le Goff W, Lesnik P, Guerin M. Reduced Reverse Cholesterol Transport Efficacy in Healthy Men with Undesirable Postprandial Triglyceride Response. Biomolecules. 2020 May 25;10(5):810. doi: 10.3390/biom10050810.

  PMID: 32466286 BACKGROUND

• Galier S, Darabi M, Ma F, Materne C, Guillas I, Le Goff W, Kontush A, Guerin M. Reduced Capacity of High-Density Lipoprotein to Acquire Free Cholesterol From Triglyceride-Rich Lipoproteins Is Associated With Elevated Postprandial Hypertriglyceridemia in Healthy Men. J Am Heart Assoc. 2024 Aug 6;13(15):e034770. doi: 10.1161/JAHA.123.034770. Epub 2024 Jul 31.

  PMID: 39082393 BACKGROUND

Study Officials

• Karim Ammour

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Same intervention for everyone, two different groups

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: April 12, 2017
• Study Start: September 21, 2011
• Primary Completion: November 21, 2015
• Study Completion: November 21, 2015
• Last Updated: September 3, 2025

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)