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

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ClinicalTrials.gov Identifier: NCT03371862
Recruitment Status : Not yet recruiting
First Posted : December 13, 2017
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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

Condition or disease Intervention/treatment Phase
Short Bowel Syndrome Drug: Liraglutide Pen Injector [Victoza] Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients.
Estimated Study Start Date : October 28, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Test group Drug: Liraglutide Pen Injector [Victoza]
Pilot study of liraglutide in patients with short bowel.




Primary Outcome Measures :
  1. Improvement in parenteral support [ Time Frame: 20 weeks post start of drug ]
    Improvement of parenteral support on 20 weeks of Liraglutide


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Days/Nights not requiring PS [ Time Frame: 20 weeks ]
    Days/Nights not requiring PS

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371862


Contacts
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Contact: Siddhartha Oke, MBBS 0208 235 4196 soke@nhs.net

Locations
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United Kingdom
St Mark's Hospital Recruiting
Harrow, United Kingdom, HA1 3UJ
Contact: Siddhartha Oke, MBBS    02082354196    soke@nhs.net   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Siddhartha Oke Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03371862     History of Changes
Other Study ID Numbers: 17IC3834
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Imperial College London:
Liraglutide
Victoza
Additional relevant MeSH terms:
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Liraglutide
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists