Back to resultsPlasma Lipid Response to Glucose Drink
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 Dr. Bookman.
- 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 ezetemibe or bile acid sequestrants
- Unstable cardiac or respiratory disease
- Any changes to medication in the preceding month.
Sites / Locations
- Tornto General Hospital, UHN
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Glucose
Water
Arm Description
50 grams of glucose in 50 ml water
50 ml water
Outcomes
Primary Outcome Measures
Blood lipid responses to glucose drink
Blood lipid levels are measured after drinking a glucose solution
Secondary Outcome Measures
Full Information
NCT ID
NCT03435432
First Posted
February 9, 2018
Last Updated
February 9, 2018
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03435432
Brief Title
Plasma Lipid Response to Glucose Drink
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
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
June 16, 2016 (Actual)
Study Completion Date
June 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
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 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.
Detailed Description
Participants are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 hours later, they drink 50 grams of glucose in 50 ml of water in one visit and 50 ml of water in another. The 2 visits are randomized. Blood samples are taken before and after they drink the high fat liquid formula, and continued until 3 hours after they drink glucose or water. Lipid levels in the blood samples are measured in the lab.
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
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glucose
Arm Type
Active Comparator
Arm Description
50 grams of 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
Blood lipid responses to glucose drink
Description
Blood lipid levels are measured after drinking a glucose solution
Time Frame
8 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 Dr. Bookman.
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 ezetemibe 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
12. IPD Sharing Statement
Plan to Share IPD
No
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Plasma Lipid Response to Glucose Drink
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