The Use of DPP-4 Inhibitors in Short Bowel Syndrome

NCT ID: NCT02653131

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-04-30

Brief Summary

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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

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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.

Conditions

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Short Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DPP-4

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

Group Type EXPERIMENTAL

Dipeptidyl peptidase-4 inhibitor

Intervention Type DRUG

NO DPP

no therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dipeptidyl peptidase-4 inhibitor

Intervention Type DRUG

Other Intervention Names

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Sitagliptin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanley Dudrick's Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stanislaw Klek

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanley Dudrick's Memorial Hospital

Skawina, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 24615689 (View on PubMed)

Other Identifiers

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GLP-1

Identifier Type: -

Identifier Source: org_study_id

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