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

Glucose-stimulated Gut Lipid Release



Sponsors


Source

University Health Network, Toronto

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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 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.

Detailed 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.

Overall Status

Completed

Start Date

2015-10-16

Completion Date

2017-08-11

Primary Completion Date

2017-08-11

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Visualization of lipid stores in the gut
6-10 hours

Secondary Outcome

Measure

Time Frame

Analysis of proteins in the gut
6-10 hours

Enrollment

46

Condition


Intervention

Intervention Type

Dietary Supplement

Intervention Name


Description

glucose drink

Arm Group Label

Glucose


Intervention Type

Dietary Supplement

Intervention Name


Description

control

Arm Group Label

Water



Eligibility

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
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

Gender

All

Minimum Age

18 Years

Maximum Age

60 Years

Healthy Volunteers

Accepts Healthy Volunteers


Location

Facility

Tornto General Hospital, UHN
Toronto Ontario M5G 1L7 Canada
Kensington Screening Clinic
Toronto Ontario M5T 3A9 Canada

Location Countries

Country

Canada


Verification Date

2018-03-01

Lastchanged Date

2018-03-12

Firstreceived Date

2018-02-09

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Glucose

Arm Group Type

Active Comparator

Description

50 grams glucose in 50 ml water


Arm Group Label

Water

Arm Group Type

Placebo Comparator

Description

50 ml water



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Basic Science

Masking

None (Open Label)


Study First Submitted

February 9, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

March 12, 2018

Last Update Submitted Qc

March 12, 2018

Last Update Posted

March 13, 2018


ClinicalTrials.gov processed this data on March 13, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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