Back to resultsGlucose-stimulated Gut Lipid Release
Primary Purpose
Hyperlipidemias
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Glucose
Water
Sponsored by
About this trial
This is an interventional basic science trial for Hyperlipidemias
Eligibility 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
Sites / Locations
- Tornto General Hospital, UHN
- Kensington Screening Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glucose
Water
Arm Description
50 grams glucose in 50 ml water
50 ml water
Outcomes
Primary Outcome Measures
Visualization of lipid stores in the gut
Electron microscopy observation gut samples in response to glucose versus water drink
Secondary Outcome Measures
Analysis of proteins in the gut
Proteomics analysis of gut samples in response to glucose versus water drink
Full Information
NCT ID
NCT03464240
First Posted
February 9, 2018
Last Updated
March 12, 2018
Sponsor
University Health Network, Toronto
Collaborators
Kensington Screening Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03464240
Brief Title
Glucose-stimulated Gut Lipid Release
Official Title
Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 16, 2015 (Actual)
Primary Completion Date
August 11, 2017 (Actual)
Study Completion Date
August 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Kensington Screening Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucose
Arm Type
Active Comparator
Arm Description
50 grams glucose in 50 ml water
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
50 ml water
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
glucose drink
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Intervention Description
control
Primary Outcome Measure Information:
Title
Visualization of lipid stores in the gut
Description
Electron microscopy observation gut samples in response to glucose versus water drink
Time Frame
6-10 hours
Secondary Outcome Measure Information:
Title
Analysis of proteins in the gut
Description
Proteomics analysis of gut samples in response to glucose versus water drink
Time Frame
6-10 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Tornto General Hospital, UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1L7
Country
Canada
Facility Name
Kensington Screening Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Glucose-stimulated Gut Lipid Release
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