Plasma Lipid Response to Glucose Drink

Not Applicable

Completed

• Conditions: Hyperlipidemias
• Interventions: Dietary Supplement: Glucose; Dietary Supplement: Water

• Registration Number: NCT03435432
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study Start: 2016-03-10
• Primary Completion: 2016-06-16
• Study Completion: 2016-06-16
• Status Verified: 2018-01
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Last Update Submitted: 2018-02-09
• Study First Posted: 2018-02-19
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Glucose	Glucose	50 grams of glucose in 50 ml water
Water	Water	50 ml water

Primary Outcome Measures

Name	Time	Method
Blood lipid responses to glucose drink	8 hours	Blood lipid levels are measured after drinking a glucose solution

Trial Locations

Locations (1)

Tornto General Hospital, UHN; 🇨🇦 Toronto, Ontario, Canada