Exendin-9,39 and Satiety After Bariatric Surgery
1 other identifier
interventional
29
1 country
1
Brief Summary
The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jun 2016
Typical duration for not_applicable obesity
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
First Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
May 20, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedResults Posted
Study results publicly available
May 1, 2020
CompletedMay 1, 2020
April 1, 2020
3.1 years
May 16, 2016
April 9, 2020
April 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caloric Intake
caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal
5 hours
Secondary Outcomes (1)
Gastrointestinal Transit Measured Using Scintigraphy
4 hours
Study Arms (2)
Saline
PLACEBO COMPARATOR0.9% NaCL (saline) intravenously for 6 hours.
Exendin-9,39
ACTIVE COMPARATORExendin-9,39 intravenously for 6 hours.
Interventions
Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.
Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.
Eligibility Criteria
You may qualify if:
- Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years
- Healthy, with no active systemic illness
You may not qualify if:
- Pregnancy
- Functional or organic bowel symptoms
- Systemic illness
- Diabetes
- Bariatric surgery \> 2 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- The Obesity Societycollaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Publications (1)
Kittah E, Camilleri M, Jensen MD, Vella A. A Pilot Study Examining the Effects of GLP-1 Receptor Blockade Using Exendin-(9,39) on Gastric Emptying and Caloric Intake in Subjects With and Without Bariatric Surgery. Metab Syndr Relat Disord. 2020 Nov;18(9):406-412. doi: 10.1089/met.2020.0049. Epub 2020 Aug 20.
PMID: 32833560DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adrian Vella
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Adrian Vella
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, FRCP (Edin), Consultant Division or Endocrinolgy, Diabetes and Nutrition
Study Record Dates
First Submitted
May 16, 2016
First Posted
May 20, 2016
Study Start
June 1, 2016
Primary Completion
July 1, 2019
Study Completion
December 1, 2019
Last Updated
May 1, 2020
Results First Posted
May 1, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share