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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity Diabetes Roux-en-Y Gastric Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Saline

a saline infusion will be started and maintained till the end of the study at 1300 (300 minutes).

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Exendin-9,39 @ 300

Exendin-9,39 @ 300pmol/kg/min

Group Type ACTIVE_COMPARATOR

Exendin-9,39

Intervention Type DRUG

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

Exendin-9,39 @ 750

Exendin-9,39 @ 750pmol/kg/min

Group Type ACTIVE_COMPARATOR

Exendin-9,39

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Saline

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No