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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02128581

Enrollment

Registered

2014-05-01

Start date

2014-05-31

Completion date

2019-07-31

Last updated

2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Diabetes, Roux-en-Y Gastric Bypass

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.

Interventions

DRUGExendin-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

OTHERSaline

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026