The Use of DPP-4 Inhibitors in Short Bowel Syndrome | NCT02653131

Studies
The Use of DPP-4 Inhibitors in Short Bowel Syndrome

NCT02653131

Sponsor

Stanley Dudrick's Memorial Hospital

Status

Terminated

Last Update Posted

Apr 15, 2020Actual

Enrollment

8Actual

Phase

Phase 4

Conditions

Short Bowel Syndrome

Interventions

Dipeptidyl peptidase-4 inhibitor

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

too many side-effects

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Apr 2020Actual

Completion Date

Apr 2020Actual

First Submitted Date

Jan 10, 2016

First Submission Date that Met QC Criteria

Jan 10, 2016

First Posted Date

Jan 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2020

Last Update Posted Date

Apr 15, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stanislaw Klek, Assoc. Prof., Stanley Dudrick's Memorial HospitalPrincipal Investigator

Lead Sponsor

Stanley Dudrick's Memorial HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DPP-4	Experimental	The administration of the DPP-4 inhibitor in the form of a pill once per day	Drug: Dipeptidyl peptidase-4 inhibitor
NO DPP	No Intervention	no therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dipeptidyl peptidase-4 inhibitor	Drug		DPP-4	Sitagliptin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of intestinal absorption	the use of DPP-4 inhibitor results in the better intestinal absorption	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanley Dudrick's Memorial Hospital		Skawina		32-050	Poland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24615689	Background	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.

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D054873	Dipeptidyl-Peptidase IV Inhibitors
D000068900	Sitagliptin Phosphate

ID	Term
D011480	Protease Inhibitors
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions