Glucose-stimulated Gut Lipid Release

Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans

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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Dietary supplement: Glucose; Dietary supplement: Water

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
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1L7
      • Tornto General Hospital, UHN
    • Toronto, Ontario, Canada, M5T 3A9
      • Kensington Screening Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water; 50 ml water	Dietary supplement: Water; control
Active Comparator: Glucose; 50 grams glucose in 50 ml water	Dietary supplement: Glucose; glucose drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization of lipid stores in the gut	Electron microscopy observation gut samples in response to glucose versus water drink	6-10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of proteins in the gut	Proteomics analysis of gut samples in response to glucose versus water drink	6-10 hours

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Kensington Screening Clinic

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2015
• Primary Completion (Actual): August 11, 2017
• Study Completion (Actual): August 11, 2017

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: Glucose Biopsy 15-9025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No