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Glucose-stimulated Gut Lipid Release

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ClinicalTrials.gov Identifier: NCT03464240
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Kensington Screening Clinic
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
During dietary fat absorption, the gut packages the majority of the fats into lipid particles that are secreted into blood circulation. The gut is also capable of storing a considerable amount of fats that can be released at a later time upon receiving certain stimulus signals. One of the signals is glucose ingestion. This protocol examines how glucose ingestion releases gut lipid store. Participants drink a fatty formula and 5-9 hours later drink either a glucose solution or water (as control). One hour later, duodenal biopsy specimen are taken for analysis of lipid stores in the gut cells.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Dietary Supplement: Glucose Dietary Supplement: Water Not Applicable

Detailed Description:
Participants undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 to 9 hours later, half of the participants drink 50 grams of glucose in 50 ml of water. The other half drink 50 ml of water. 1 hour later, duodenal biopsy specimen are collected and stored for analysis of lipid stores in the gut using electron microscopy and proteins using proteomics.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
Actual Study Start Date : October 16, 2015
Actual Primary Completion Date : August 11, 2017
Actual Study Completion Date : August 11, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water
Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: Glucose
50 grams glucose in 50 ml water
Dietary Supplement: Glucose
glucose drink

Placebo Comparator: Water
50 ml water
Dietary Supplement: Water
control




Primary Outcome Measures :
  1. Visualization of lipid stores in the gut [ Time Frame: 6-10 hours ]
    Electron microscopy observation gut samples in response to glucose versus water drink


Secondary Outcome Measures :
  1. Analysis of proteins in the gut [ Time Frame: 6-10 hours ]
    Proteomics analysis of gut samples in response to glucose versus water drink



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by endoscopy doctor.
  • Body mass index 20 to 27 kg/m2

Exclusion Criteria:

  • Patients with active inflammatory bowel disease
  • Patients with Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
  • Patients with active bowel malignancy
  • Patients with diabetes mellitus or known/ suspected motility disorders of the gut
  • Patients with decompensated liver disease
  • Patients on ezetimibe or bile acid sequestrants
  • Unstable cardiac or respiratory disease
  • Any changes to medication in the preceding month

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): NCT03464240


Locations
Canada, Ontario
Tornto General Hospital, UHN
Toronto, Ontario, Canada, M5G 1L7
Kensington Screening Clinic
Toronto, Ontario, Canada, M5T 3A9
Sponsors and Collaborators
University Health Network, Toronto
Kensington Screening Clinic

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03464240     History of Changes
Other Study ID Numbers: Glucose Biopsy 15-9025
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases