The Use of DPP-4 Inhibitors in Short Bowel Syndrome

Sponsor

Stanley Dudrick's Memorial Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02653131

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The inhibition of Dipeptidyl peptidase-4 should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

Condition or Disease	Intervention/Treatment	Phase
Short Bowel Syndrome	Drug: Dipeptidyl peptidase-4 inhibitor	Phase 4

Detailed Description

The only effective (to some extend drug) in short bowel syndrome is Glucacone-like peptide 4. Its price is, however, to high to really change the treatment strategy for intestinal failure. The Dipeptidyl peptidase-4 inhibitor, which a drug which is commonly used in the treatment of diabetes mellitus type II, should increase the concentration of glucagone-like peptide 1 and 2, and the increase of the latter should increase the absorptive capacity of the intestine.

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Use of Dipeptidyl Peptidase-4 Inhibitor Influences the Absorption of Intestine in Short Bowel Syndrome

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Apr 1, 2020

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DPP-4 The administration of the DPP-4 inhibitor in the form of a pill once per day	Drug: Dipeptidyl peptidase-4 inhibitor Other Names: Sitagliptin
No Intervention: NO DPP no therapy

Arm

Intervention/Treatment

Experimental: DPP-4

The administration of the DPP-4 inhibitor in the form of a pill once per day

Drug: Dipeptidyl peptidase-4 inhibitor

Other Names:

Sitagliptin

No Intervention: NO DPP

no therapy

Outcome Measures

Primary Outcome Measures

Improvement of intestinal absorption [12 months]
the use of DPP-4 inhibitor results in the better intestinal absorption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients receiving home parenteral nutrition (HPN) because of short bowel syndrome for at least 12 months
stable metabolic status
benign disease

Exclusion Criteria:

HPN < 12 months
metabolically unstable
cancer as the reason for intestinal failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanley Dudrick's Memorial Hospital	Skawina		Poland	32-050

Sponsors and Collaborators

Stanley Dudrick's Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Jeppesen PB. Pharmacologic options for intestinal rehabilitation in patients with short bowel syndrome. JPEN J Parenter Enteral Nutr. 2014 May;38(1 Suppl):45S-52S. doi: 10.1177/0148607114526241. Epub 2014 Mar 10. Review.

Responsible Party:

Stanislaw Klek, Assoc. Prof., Stanley Dudrick's Memorial Hospital

ClinicalTrials.gov Identifier:

NCT02653131

Other Study ID Numbers:

GLP-1

First Posted:

Jan 12, 2016

Last Update Posted:

Apr 15, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Stanislaw Klek, Assoc. Prof., Stanley Dudrick's Memorial Hospital

Short bowel syndrome

Additional relevant MeSH terms:

Short Bowel Syndrome

Syndrome

Sitagliptin Phosphate

Dipeptidyl-Peptidase IV Inhibitors

Study Results

No Results Posted as of Apr 15, 2020