Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS) (SLIPS)

August 12, 2020 updated by: Imperial College London

Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients.

Pilot study looking at the effect on Liraglutide in the reduction of parenteral support in patients with short bowel.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Short bowel (≤200cm) as a result of major intestinal resection (e.g. due to injury, volvulus, vascular disease, Crohn's disease).
  2. Jejunostomy patients only
  3. 12 continuous months of parenteral support (PS) dependency prior to enrolment.
  4. PS required at least 3 times per week to meet their caloric, fluid or electrolyte needs due to on-going malabsorption.

  5. Stable PS for at least 4 consecutive weeks immediately prior to first dose of liraglutide. Stability is described as:

    1. Actual PS usage should match prescribed PS;
    2. Baseline 48-hour urine output is 1-2 L/24 hours.
  6. Body mass index ≥ 19.5 kg/m2.

  7. Adequate hepatic and renal function:

    1. Total bilirubin within the normal range;
    2. Alanine aminotransferase (ALT) ≤ 2.5x upper limit of normal;
    3. Serum creatinine ≤1.5x upper limit of normal.
  8. Stable dosage for > 4 weeks, prior to baseline evaluations, of anti-motility and anti-diarrhoeal agents, H2 antagonists, proton pump inhibitors, bile sequestering agents and oral rehydration solutions.
  9. Female subjects must be on acceptable method of contraception for a minimum of 4 weeks prior to the start of the trial; Acceptable methods of contraception would be a barrier form of contraception, oral contraceptive pill, contraceptive injection or implant or intrauterine implanted device.

Exclusion Criteria:

  • Patients < 18 years of age
  • Pregnancy (Female subjects who are not surgically sterile or post menopausal (defined as aged 55 years or older and/or at least 2 years have elapsed since the last menses) or who are not using medically acceptable methods of birth control during and for 30 days after the treatment period. Acceptable methods of contraception would be a barrier form of contraception, oral contraceptive pill, contraceptive injection or implant or intrauterine implanted device.
  • Active malignancy
  • Previous malignancy within the past 5 years
  • History of multiple endocrine neoplasia type 2 (MEN 2)
  • Personal history or family history of medullary thyroid cancer
  • Raised serum calcitonin (a biomarker for medullary thyroid cancer) at beginning of trial period
  • History of cardiac failure
  • Concurrent use of diuretics
  • Previous history of pancreatitis
  • Recent use of other incretin based therapy in the previous 3 months
  • Concurrent use of octreotide
  • Type 1 or Type 2 diabetes
  • Alcohol or drug abuse in last year
  • > 4 hospitalisations related to short bowel or its treatment over the previous year
  • Any hospitalisation 30 days prior to screening
  • Introduction or dose adjustment of immunosuppressant for inflammatory bowel disease within 6 months, or treatment with biologics within the past 6 months (systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, MMF, infliximab, adalimumab, vedolizumab)
  • BMI < 19 kg/m2 or > 27kg/m2 (An upper cut-off BMI of > 27kg/m2 has been chosen, as in these patients, there is often a desire to reduce BMI which will conflict with the study design by adding another variable)
  • Scleroderma/radiation enteritis/coeliacs disease/refractory or tropical sprue
  • Liver and renal function outside the inclusion range

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test group
Drug: Liraglutide Pen Injector [Victoza]
Pilot study of liraglutide in patients with short bowel.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in parenteral support
Time Frame: 20 weeks post start of drug
Improvement of parenteral support on 20 weeks of Liraglutide
20 weeks post start of drug

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in quality of life
Time Frame: 20 weeks post start of drug
Improvement in Euroqol EQ5-D score. Level 1: indicating no problem, Level 5: indicating extreme problems.
20 weeks post start of drug
Duration of response
Time Frame: 20 weeks
Duration of response i.e. proportion of subjects who maintain reduction in weekly PN volume from baseline at week 20.
20 weeks
Days/Nights not requiring PS
Time Frame: 20 weeks
Days/Nights not requiring PS
20 weeks
Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations
Time Frame: 20 weeks
Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Siddhartha Oke, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17IC3834

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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