Exenatide on GI Motor Function and Permeability in Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01818648
• Other study ID #: 12-008505
• Status: Withdrawn
• Phase: Phase 4
• First received: February 28, 2013
• Last updated: January 10, 2014
• Start date: March 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	No
Other	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.	No
Primary	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.	No
Secondary	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. .	No