Plasma Lipid Response to Glucose Drink

Hyperlipidemias Clinical Trial

Official title:

Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435432
• Other study ID #: Glucose Plasma 15-9025
• Status: Completed
• Phase: N/A
• First received: February 9, 2018
• Last updated: February 9, 2018
• Start date: March 10, 2016
• Est. completion date: June 16, 2016

Study information

• Verified date: January 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 16, 2016
• Est. primary completion date: June 16, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Glucose
Glucose drink
• Water
Control

Locations

Country	Name	City	State
Canada	Tornto General Hospital, UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood lipid responses to glucose drink	Blood lipid levels are measured after drinking a glucose solution	8 hours