Location of GLP-1 Release
Location of Glucagon-Like Peptide (GLP)-1 Release
1 other identifier
observational
12
1 country
1
Brief Summary
Background: Physicians do not have a unified, scientifically tested theory of causation for obesity and its comorbidities, nor do they have explanations for the mechanics of the metabolic/bariatric surgery procedures. Integral to proffered hypotheses are the actions of the hormones glucagon-like peptide (GLP-1), peptide YY (PYY), and leptin. Study objective: To obtain blood levels of GLP-1, PYY, and leptin after stimulation of the terminal ileum and cecum by a static infusion of a food hydrolysate in morbidly obese patients undergoing a duodenal switch procedure. Methods: Plasma levels of GLP-1, PYY, and leptin were obtained at 0, 30, 60, 90, and 120 minutes after instillation of 240 ml of a food hydrolysate into the ileum or cecum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 10, 2014
CompletedFirst Posted
Study publicly available on registry
January 15, 2014
CompletedNovember 1, 2019
October 1, 2019
1.8 years
January 10, 2014
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
GLP-1
GLP- levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
2 hours
peptide YY (PYY)
PYY levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
2 hours
Leptin
Leptin levels were measured at intervals over two hours after static bowel food hydrolysate was infused, in patients undergoing scheduled open duodenal switch procedure.
2 hours
Study Arms (2)
Cecum
Food hydrolysate instilled into terminal cecum of patient undergoing open duodenal switch procedure. Blood samples were then obtained at baseline and at 0, 30, 60, 90, and 120 minutes for analysis of circulating GLP-1, PYY, and leptin.
Ileum
Food hydrolysate instilled into terminal ileum of patient undergoing open duodenal switch procedure. Blood samples were then obtained at baseline and at 0, 30, 60, 90, and 120 minutes for analysis of circulating GLP-1, PYY, and leptin.
Eligibility Criteria
Study population consisted of morbidly obese individuals who had decided to undergo open duodenal switch surgery
You may qualify if:
- Any patient who was qualified and approved for bariatric surgery and elected to undergo open duodenal switch procedure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henry Buchwald, MD, PhD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2014
First Posted
January 15, 2014
Study Start
November 1, 2011
Primary Completion
August 1, 2013
Study Completion
October 1, 2013
Last Updated
November 1, 2019
Record last verified: 2019-10