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Effect of SB CD on Chylomicron

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ClinicalTrials.gov Identifier: NCT03496818
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
It is often suggested that lymphatic vessels are ineffective in transporting cargo in Crohn's disease. Our own work on surgically resected tissue supports this concept (1), but the concept has not been directly tested. Chylomicrons are packaged lipids from the diet with an obligatory absorption route through the lymphatic vasculature to reach host plasma. This protocol takes an approach to directly quantify chylomicron secretion using a fatty meal that incorporates stable isotopic tracers for trioleate and cholesterol in the meal. We will collect baseline plasma and then plasma every 30 minutes for 5.5 hours to chart the kinetic and magnitude of chylomicron secretion and transport in all subjects using mass spectrometry analysis. We will characterize a wide variety of parameters on the chylomicrons as well using ELISA. Infusions i.v. of stable isotope labeled triglyceride and glycerol will allow us to consider whether there are changes in VLDL metabolism that could account for differences in chylomicron handling once the chylomicrons are secreted into plasma. Collection and analysis of breath samples will also be carried to normalize against possible incomplete lipid absorption in some subjects.

Condition or disease
Crohn Disease

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Small Bowel Crohn's Disease on Chylomicron Secretion After Ingestion of a Fatty Meal
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort
Crohn's Disease
Participants age 18-80 years old, diagnosed with Crohn's disease with active disease based on MR enterography or CT enterography confirmed within the prior 30 days.
Healthy controls
Participants age 18-80 years old, with no diagnosis of inflammatory bowel disease.



Primary Outcome Measures :
  1. Chylomicron transport rate and magnitude [ Time Frame: 1 day of Enrollment ]
    % of meal-delivered triglyceride (trioleate) tracer recovered in the chylomicron fraction of plasma over a 5.5 h time course will be used to quantify chylomicron transport rate and magnitude


Secondary Outcome Measures :
  1. Tracer kinetic calculations [ Time Frame: 1 day of Enrollment ]
    Total plasma triglycerides, cholesterol, free fatty acids will be used for tracer kinetic calculations, as well as to calculate metabolic area under the curves

  2. Maturation of the lipoproteins in plasma [ Time Frame: 1 day of Enrollment ]
    Quantification of plasma apoA-1, apoA-IV, apoB48, apoE, apoCII, apoM and the presence of these proteins in chylomicron, VLDL, LDL, and HDL will serve to characterize the maturation of the lipoproteins in plasma over time in CD versus control samples

  3. NMR analysis [ Time Frame: 1 day of Enrollment ]
    NMR analysis will be used to determine the size of various lipoproteins in the plasma over the time course

  4. Chylomicron secretion [ Time Frame: 1 day of Enrollment ]
    Plasma VEGF-C measurement will be used to determine if chylomicron secretion correlates with release of the lymphatic hormone VEGF-C

  5. Lipid uptake and excretion [ Time Frame: 1 day of Enrollment ]
    % of meal-delivered triglyceride tracer recovered in breath samples will be used to measure exogenous lipid uptake and excretion


Biospecimen Retention:   Samples Without DNA
Stool, Blood


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from the Washington University School of Medicine IBD Center, Washington University's Volunteers for Health, the Center for Community Based Research, and IBD clinics affiliated with Washington University in the surrounding St. Louis community.
Criteria

Inclusion criteria (experimental group):

  1. Age 18-80 year's old.
  2. Diagnosed with Crohn's disease.
  3. Active small bowel Crohn's disease on MR enterography or CT enterography confirmed within the prior 30 days.
  4. Inflammatory markers (eg.,. CRP, ESR) elevated above the upper limit of normal.
  5. Ability to provide informed consent.

Inclusion criteria (control group):

  1. Age 18-80 years old.
  2. Ability to provide informed consent.
  3. No diagnosis of inflammatory bowel disease.

Exclusion Criteria

  1. Active tobacco use.
  2. A history of diabetes mellitus.
  3. A history of hyperlipidemia.
  4. A history of thyroid dysfunction.
  5. A history of hepatic, cardiac, renal or endocrine dysfunction.
  6. A history of cancer requiring systemic chemotherapy
  7. Prior radiation therapy to pelvis or abdomen
  8. Taking medications (current or past 30 days) known to alter plasma lipid levels including statins, corticosteroids (oral, IV or topical), bile acid sequestrants, thyroid drugs, or fibrates.
  9. Currently pregnant or trying to become pregnant.
  10. History of abdominal or pelvic surgery.
  11. Complicated small bowel CD with obstruction, penetrating disease and/or abscess.
  12. Recent surgery of any type within the last 30 days that, in the discretion of the principal investigator, might affect the study or pose risk to the subject Exclusion for control group: all of the above and no recent participation in other studies as a control.

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): NCT03496818


Contacts
Contact: Gwendolyn J Randolph, Ph.D. 314 286-2345 gjrandolph@wustl.edu
Contact: Paul Huang 267-886-3669 ibdstudy@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Paul Huang    267-886-3669    ibdstudy@wustl.edu   
Contact: Darren Nix    314-362-3201    nixd@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03496818     History of Changes
Other Study ID Numbers: 201712103
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases