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

NCT02128581 | Completed Phase 1

• 3 other identifiers: 14-002150R01DK082396UL1RR024150
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes; Roux-en-Y Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• Calories consumed during buffet meal test

  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.

  approximately 300 minutes after initiation

Study Arms (3)

Saline

PLACEBO COMPARATOR

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

Other: Saline

Exendin-9,39 @ 300

ACTIVE COMPARATOR

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

Drug: Exendin-9,39

Exendin-9,39 @ 750

ACTIVE COMPARATOR

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

Drug: Exendin-9,39

Interventions

Exendin-9,39 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 @ 300; Exendin-9,39 @ 750

Saline OTHER

Saline

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Adrian Vella, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Endocrinology

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: May 1, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2019
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

US (1)