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

Short Bowel Syndrome Clinical Trial

— SLIPS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03371862
• Other study ID #: 17IC3834
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 20, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Short Bowel Syndrome

Intervention

Drug:
• Liraglutide Pen Injector [Victoza]
Pilot study of liraglutide in patients with short bowel.

Locations

Country	Name	City	State
United Kingdom	St Mark's Hospital	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in parenteral support	Improvement of parenteral support on 20 weeks of Liraglutide	20 weeks post start of drug
Secondary	Improvement in quality of life	Improvement in Euroqol EQ5-D score. Level 1: indicating no problem, Level 5: indicating extreme problems.	20 weeks post start of drug
Secondary	Duration of response	Duration of response i.e. proportion of subjects who maintain reduction in weekly PN volume from baseline at week 20.	20 weeks
Secondary	Days/Nights not requiring PS	Days/Nights not requiring PS	20 weeks
Secondary	Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations	Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations	20 weeks