Clinical trial NCT03371862: Liraglutide on Decreasing Parenteral Support in Short Bowel Patients (SLIPS)
Official title: Pilot Study of the GLP-1 Agonist, Liraglutide, on Decreasing Parenteral Support Requirements in Short Bowel Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Short Bowel Syndrome
Keywords: Liraglutide
Victoza
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Improvement in parenteral support
timeFrame: 20 weeks post start of drug
Secondary outcomes:
measure: Improvement in quality of life
timeFrame: 20 weeks post start of drug
measure: Duration of response
timeFrame: 20 weeks
measure: Days/Nights not requiring PS
timeFrame: 20 weeks
measure: Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: St Mark's Hospital
Study officials:
affiliation: Imperial College London
name: Siddhartha Oke
role: PRINCIPAL_INVESTIGATOR
References: