Plasma Lipid Response to Glucose Drink

• ClinicalTrials.gov Identifier: NCT03435432
• Recruitment Status: Completed
• First Posted: February 19, 2018
• Last Update Posted: February 19, 2018
• Sponsor: University Health Network, Toronto
• Information provided by (Responsible Party): University Health Network, Toronto

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.

Condition or disease	Intervention/treatment	Phase
Hyperlipidemias	Dietary Supplement: Glucose; Dietary Supplement: Water	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
• Actual Study Start Date: March 10, 2016
• Actual Primary Completion Date: June 16, 2016
• Actual Study Completion Date: June 16, 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Glucose; 50 grams of glucose in 50 ml water	Dietary Supplement: Glucose; Glucose drink
Placebo Comparator: Water; 50 ml water	Dietary Supplement: Water; Control

Outcome Measures

Primary Outcome Measures :

1. Blood lipid responses to glucose drink [ Time Frame: 8 hours ]
   Blood lipid levels are measured after drinking a glucose solution

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Canada, Ontario

Tornto General Hospital, UHN

Toronto, Ontario, Canada, M5G 1L7

Sponsors and Collaborators

University Health Network, Toronto

More Information

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT03435432
• Other Study ID Numbers: Glucose Plasma 15-9025
• First Posted: February 19, 2018
• Last Update Posted: February 19, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases