Back to resultsExenatide on GI Motor Function and Permeability in Short Bowel Syndrome
Primary Purpose
Short Bowel Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Exenatide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Short Bowel Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exenatide
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01818648
Brief Title
Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Study was withdrawn by PI due to decision to study a different medication.
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Exenatide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 24hr Gastrointestinal and Colonic Transit before and after Exenatide vs placebo
Description
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
Time Frame
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 Measure Information:
Title
Change in 24hr Intestinal Permeability before and after administration of Exenatide vs placebo
Description
To measure intestinal permeability to mannitol and lactulose in patients with short bowel syndrome before and after administration of Exenatide compared to placebo
Time Frame
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 Pre-specified Outcome Measures:
Title
Change in 24hr Stool Weight before and after administration of Exenatide vs placebo
Description
To measure stool weight in patients with short bowel syndrome before and after administration of Exenatide compared to placebo.
Time Frame
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.
Title
Change in 24hr Urine Volume before and after administration of Exenatide vs placebo
Description
To measure urine volume in patients with short bowel syndrome before and after administration of Exenatide compared to placebo.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Camilleri, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome
We'll reach out to this number within 24 hrs