Intestines and Liver Contribution to Fasting Postprandial Hypertriglyceridemia

NCT02898142 | Completed

• 1 other identifier: P111003
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia; Metabolic Syndrome

Keywords

Postprandial test; Metabolic syndrime; HTG

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Apo B48 peak plasma concentration

  the highest level of Apo B48 during the test of 6 hours (day of sampling after postprandial test)

Other Outcomes (5)

• Apo B100 plasma concentration

  every hour for 6 hours (day of sampling after postprandial test)

• Apo B100 peak plasma concentration

  the highest level of Apo B100 during the test of 6 hours

• Triglycerides peak plasma concentration

  The highest level of triglycerides during the test of 6 hours

Study Arms (2)

Isolated HTG without metabolic syndrome

EXPERIMENTAL

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

HTG with metabolic syndrome

EXPERIMENTAL

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

Interventions

Postprandial test OTHER

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.

HTG with metabolic syndrome; Isolated HTG without metabolic syndrome

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Fasting glucose \> 5.6 mmol / L but \<7.0 mmol / L and
• Waist perimeter \>94 cm in men and \>80cm in women.

You may not qualify if:

• Diabetic Patient
• Any recent changes (less than one month) of any treatment
• Patient participating in another clinical study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié Salpetriere Hospital

Paris, 75013, France

Location

Related 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. No abstract available.

  PMID: 25332284 BACKGROUND

MeSH Terms

Conditions

Hypertriglyceridemia; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Study Officials

• Philippe Giral, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: September 13, 2016
• Study Start: February 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 29, 2016

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)