NCT02653131

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

4.3 years

First QC Date

January 10, 2016

Last Update Submit

April 13, 2020

Conditions

Keywords

Short bowel syndrome

Outcome Measures

Primary Outcomes (1)

  • Improvement of intestinal absorption

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

    12 months

Study Arms (2)

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

Also known as: Sitagliptin
DPP-4

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

Related Publications (1)

  • 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.

    PMID: 24615689BACKGROUND

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Dipeptidyl-Peptidase IV InhibitorsSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of DrugsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

January 10, 2016

First Posted

January 12, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

All data is a part of a research

Locations