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No participants recruited. Not able to recruit due to COVID 19.
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Pilot study looking at the effect on Liraglutide in the reduction of parenteral support in patients with short bowel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide Pen Injector [Victoza] | Drug | Pilot study of liraglutide in patients with short bowel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in parenteral support | Improvement of parenteral support on 20 weeks of Liraglutide | 20 weeks post start of drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Duration of response | Duration of response i.e. proportion of subjects who maintain reduction in weekly PN volume from baseline at week 20. |
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Inclusion Criteria:
Short bowel (≤200cm) as a result of major intestinal resection (e.g. due to injury, volvulus, vascular disease, Crohn's disease).
Jejunostomy patients only
12 continuous months of parenteral support (PS) dependency prior to enrolment.
PS required at least 3 times per week to meet their caloric, fluid or electrolyte needs due to on-going malabsorption.
Stable PS for at least 4 consecutive weeks immediately prior to first dose of liraglutide. Stability is described as:
Body mass index ≥ 19.5 kg/m2.
Adequate hepatic and renal function:
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Siddhartha Oke | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Mark's Hospital | Harrow | HA1 3UJ | United Kingdom |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Pilot study
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| 20 weeks |
| Days/Nights not requiring PS | Days/Nights not requiring PS | 20 weeks |
| Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations | Change in plasma citrulline, GLP-1, IGF-1 and PYY concentrations | 20 weeks |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |