Plasma Lipid Response to Glucose Drink
Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
1 other identifier
interventional
6
1 country
1
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 blood lipid responses to a glucose drink. Participants drink a fatty formula and 5 hours later drink either a glucose solution or water (as control), in one of two randomized study visits. Blood lipid levels are monitored throughout the study period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2016
CompletedFirst Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedFebruary 19, 2018
January 1, 2018
3 months
February 9, 2018
February 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Blood lipid responses to glucose drink
Blood lipid levels are measured after drinking a glucose solution
8 hours
Study Arms (2)
Glucose
ACTIVE COMPARATOR50 grams of 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 Dr. Bookman.
- 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 ezetemibe 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
Study Sites (1)
Tornto General Hospital, UHN
Toronto, Ontario, M5G 1L7, 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
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2018
First Posted
February 19, 2018
Study Start
March 10, 2016
Primary Completion
June 16, 2016
Study Completion
June 16, 2016
Last Updated
February 19, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share