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A Dose-response of the Effects of Exendin-9,39 on GI Symptoms and Food Intake

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ClinicalTrials.gov Identifier: NCT02128581
Recruitment Status : Active, not recruiting
First Posted : May 1, 2014
Last Update Posted : March 7, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Adrian Vella, Mayo Clinic

Brief Summary:
Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Roux-en-Y Gastric Bypass Drug: Exendin-9,39 Other: Saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Dose-response Study of the Effects of Exendin-9,39 on Gastrointestinal Symptoms and Food Intake.
Study Start Date : May 2014
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Placebo Comparator: Saline
a saline infusion will be started and maintained till the end of the study at 1300 (300 minutes).
Other: Saline
Active Comparator: Exendin-9,39 @ 300
Exendin-9,39 @ 300pmol/kg/min
Drug: Exendin-9,39
use Exendin-9,39 @ 750pmol/kg/min and Exendin-9,39 @ 300pmol/kg/min to block endogenous GLP-1 in humans after gastric bypass and determine contribution of GLP to satiety after meal ingestion

Active Comparator: Exendin-9,39 @ 750
Exendin-9,39 @ 750pmol/kg/min
Drug: Exendin-9,39
use Exendin-9,39 @ 750pmol/kg/min and Exendin-9,39 @ 300pmol/kg/min to block endogenous GLP-1 in humans after gastric bypass and determine contribution of GLP to satiety after meal ingestion




Primary Outcome Measures :
  1. Calories consumed during buffet meal test [ Time Frame: approximately 300 minutes after initiation ]
    The calories consumed during buffet meal test at the end of each study test will help determine the effect of GLP-1 receptor blockade with Exendin-9,39 on food intake.



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who have undergone Roux en-Y Gastric Bypass at least 6 months prior to enrollment in the study.
  • Subjects without active systemic illness.

Exclusion Criteria:

  • Subjects <20 years of age will not be studied to minimize the possibility of type 1 diabetes.
  • Subjects >70 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.

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): NCT02128581


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Investigators
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Principal Investigator: Adrian Vella, MD Mayo Clinic

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Responsible Party: Adrian Vella, Consultant, Endocrinology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02128581     History of Changes
Other Study ID Numbers: 14-002150
R01DK082396 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019