Glucose-stimulated Gut Lipid Release
Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
1 other identifier
interventional
46
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2017
CompletedFirst Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedMarch 13, 2018
March 1, 2018
1.8 years
February 9, 2018
March 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Visualization of lipid stores in the gut
Electron microscopy observation gut samples in response to glucose versus water drink
6-10 hours
Secondary Outcomes (1)
Analysis of proteins in the gut
6-10 hours
Study Arms (2)
Glucose
ACTIVE COMPARATOR50 grams glucose in 50 ml water
Water
PLACEBO COMPARATOR50 ml water
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- Kensington Screening Cliniccollaborator
Study Sites (2)
Tornto General Hospital, UHN
Toronto, Ontario, M5G 1L7, Canada
Kensington Screening Clinic
Toronto, Ontario, M5T 3A9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2018
First Posted
March 13, 2018
Study Start
October 16, 2015
Primary Completion
August 11, 2017
Study Completion
August 11, 2017
Last Updated
March 13, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share