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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02128581

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), National Center for Research Resources (NCRR) (NIH)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Calories consumed during buffet meal test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Adrian Vella, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Adrian Vella, Consultant, Endocrinology, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT02128581

Other Study ID Numbers:

14-002150
R01DK082396
UL1RR024150

First Posted:

May 1, 2014

Last Update Posted:

Oct 23, 2019

Last Verified:

Oct 1, 2019

Study Results

No Results Posted as of Oct 23, 2019