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Plasma Lipid Response to Glucose Drink

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435432
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Dietary Supplement: Glucose Dietary Supplement: Water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating the Molecular Mechanisms Underpinning Glucose Stimulated Release of Stored Enteral Lipid in Humans
Actual Study Start Date : March 10, 2016
Actual Primary Completion Date : June 16, 2016
Actual Study Completion Date : June 16, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: Glucose
50 grams of glucose in 50 ml water
Dietary Supplement: Glucose
Glucose drink

Placebo Comparator: Water
50 ml water
Dietary Supplement: Water
Control




Primary Outcome Measures :
  1. Blood lipid responses to glucose drink [ Time Frame: 8 hours ]
    Blood lipid levels are measured after drinking a glucose solution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435432


Locations
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Canada, Ontario
Tornto General Hospital, UHN
Toronto, Ontario, Canada, M5G 1L7
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03435432    
Other Study ID Numbers: Glucose Plasma 15-9025
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases