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Clinical Trials/NCT03464240
NCT03464240CompletedNot Applicable

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

University Health Network, Toronto2 sites in 1 country46 target enrollmentStarted: October 16, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
2
Primary Endpoint
Visualization of lipid stores in the gut

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Glucose

Active Comparator

50 grams glucose in 50 ml water

Intervention: Glucose (Dietary Supplement)

Water

Placebo Comparator

50 ml water

Intervention: Water (Dietary Supplement)

Outcomes

Primary Outcomes

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 Outcomes

  • Analysis of proteins in the gut(6-10 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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