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The Use of DPP-4 Inhibitors in Short Bowel Syndrome (DPP-4)

Primary Purpose

Short Bowel Syndrome

Status
Terminated
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Dipeptidyl peptidase-4 inhibitor
Sponsored by
Stanley Dudrick's Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Bowel Syndrome focused on measuring Short bowel syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanley Dudrick's Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DPP-4

NO DPP

Arm Description

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

no therapy

Outcomes

Primary Outcome Measures

Improvement of intestinal absorption
the use of DPP-4 inhibitor results in the better intestinal absorption

Secondary Outcome Measures

Full Information

First Posted
January 10, 2016
Last Updated
April 13, 2020
Sponsor
Stanley Dudrick's Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02653131
Brief Title
The Use of DPP-4 Inhibitors in Short Bowel Syndrome
Acronym
DPP-4
Official Title
The Use of Dipeptidyl Peptidase-4 Inhibitor Influences the Absorption of Intestine in Short Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
too many side-effects
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
April 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanley Dudrick's Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Bowel Syndrome
Keywords
Short bowel syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DPP-4
Arm Type
Experimental
Arm Description
The administration of the DPP-4 inhibitor in the form of a pill once per day
Arm Title
NO DPP
Arm Type
No Intervention
Arm Description
no therapy
Intervention Type
Drug
Intervention Name(s)
Dipeptidyl peptidase-4 inhibitor
Other Intervention Name(s)
Sitagliptin
Primary Outcome Measure Information:
Title
Improvement of intestinal absorption
Description
the use of DPP-4 inhibitor results in the better intestinal absorption
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanley Dudrick's Memorial Hospital
City
Skawina
ZIP/Postal Code
32-050
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All data is a part of a research
Citations:
PubMed Identifier
24615689
Citation
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.
Results Reference
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The Use of DPP-4 Inhibitors in Short Bowel Syndrome

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