Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome

Acute Effects of a Glucagon-like Peptide 1 Analog, Exenatide, on Gastrointestinal Motor Function and Permeability in Patients With Short Bowel Syndrome on Home Parenteral Nutrition

We plan to examine the gastrointestinal (GI) physiologic profile of Exenatide, a glucagon-like peptide (GLP-1) analog as a possible intestino-trophic growth factor capable of inducing small bowel adaptation and regeneration in patients with short bowel syndrome (SBS), with the potential to decrease parenteral nutrition dependence.

Study Overview

• Status: Withdrawn
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: Exenatide; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patients with short bowel syndrome, between the ages of 18-85 who are dependent on parenteral nutrition for at least a year and are being closely followed by the Mayo Clinic Home Parenteral Nutrition Program (HPN) with at least one multisystem evaluation a year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exenatide; Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.	Drug: Exenatide; Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.
Placebo Comparator: Placebo; Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.	Drug: Placebo; Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24hr Gastrointestinal and Colonic Transit before and after Exenatide vs placebo	To measure gastric, small intestinal and colonic (if applicable) transit in patients with short bowel syndrome (SBS) before and after the administration of Exenatide compared to placebo	In both arms participants will undergo GI transit measurements on 2 seperate occasions for a total of 24 hours, with a wash out period of 48 hours in between transit studies.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24hr Intestinal Permeability before and after administration of Exenatide vs placebo	To measure intestinal permeability to mannitol and lactulose in patients with short bowel syndrome before and after administration of Exenatide compared to placebo	In both arms participants will undergo intestinal permeability measurements on 2 seperate occasions for 24 hours,with a wash out period of 48 hours in between permeability studies. .

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24hr Stool Weight before and after administration of Exenatide vs placebo	To measure stool weight in patients with short bowel syndrome before and after administration of Exenatide compared to placebo.	In both arms participants will collect stool weight for 24 hours in 2 seperate occasions with a wash out period of 48 hours in between collections.
Change in 24hr Urine Volume before and after administration of Exenatide vs placebo	To measure urine volume in patients with short bowel syndrome before and after administration of Exenatide compared to placebo.	In both arms participants will collect urine volume for 24 hours in 2 seperate occasions with a wash out period of 48 hours in between collections.

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 26, 2013

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: 12-008505