Glucose-stimulated Gut Lipid Release

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: NCT03464240
• Other study ID #: Glucose Biopsy 15-9025
• Status: Completed
• Phase: N/A
• First received: February 9, 2018
• Last updated: March 12, 2018
• Start date: October 16, 2015
• Est. completion date: August 11, 2017

Study information

• Verified date: March 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 how glucose ingestion releases gut lipid store. Participants drink a fatty formula and 5-9 hours later drink either a glucose solution or water (as control). One hour later, duodenal biopsy specimen are taken for analysis of lipid stores in the gut cells.

Description:

Participants undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications are recruited after obtaining informed consent. They first have a high fat liquid formula. 5 to 9 hours later, half of the participants drink 50 grams of glucose in 50 ml of water. The other half drink 50 ml of water. 1 hour later, duodenal biopsy specimen are collected and stored for analysis of lipid stores in the gut using electron microscopy and proteins using proteomics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 11, 2017
• Est. primary completion date: August 11, 2017
• 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 endoscopy doctor.

• 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 ezetimibe 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	Kensington Screening Clinic	Toronto	Ontario
Canada	Tornto General Hospital, UHN	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Kensington Screening Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization of lipid stores in the gut	Electron microscopy observation gut samples in response to glucose versus water drink	6-10 hours
Secondary	Analysis of proteins in the gut	Proteomics analysis of gut samples in response to glucose versus water drink	6-10 hours