Plasma Lipid Response to Glucose Drink

NCT ID: NCT03435432

Last Updated: 2018-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-10

Study Completion Date

2016-06-16

Brief Summary

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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

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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.

Conditions

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Hyperlipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Glucose

50 grams of glucose in 50 ml water

Group Type ACTIVE_COMPARATOR

Glucose

Intervention Type DIETARY_SUPPLEMENT

Glucose drink

Water

50 ml water

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Control

Interventions

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Glucose

Glucose drink

Intervention Type DIETARY_SUPPLEMENT

Water

Control

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tornto General Hospital, UHN

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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Glucose Plasma 15-9025

Identifier Type: -

Identifier Source: org_study_id

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