drugset / Trial / NCT07297238
Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.
RandomizedParallel-groupSingle-blindTreatment
Summary
Eligible patients were randomized into two groups: the GLP-1 group and the control group. The control group received a placebo along with standard care, without any additional GLP-1-based intervention. The GLP-1 group, in addition to standard care, received a subcutaneous injection of a GLP-1 analog (semaglutide injection) strictly according to the drug manufacturer's instructions. The initial dose of semaglutide was 0.25 mg once weekly. Treatment was continued over a 28-days period. Primary and secondary outcomes will be collected.
Timeline
- Start
- 2026-01-24
- Primary completion
- 2026-05-27
- Completion
- 2026-06-30
Publications
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- Background Bang-Berthelsen CH, Holm TL, Pyke C, Simonsen L, Sokilde R, Pociot F, Heller RS, Folkersen L, Kvist PH, Jackerott M, Fleckner J, Vilien M, Knudsen LB, Heding A, Frederiksen KS. GLP-1 Induces Barrier Protective Expression in Brunner's Glands and Regulates Colonic Inflammation. Inflamm Bowel Dis. 2016 Sep;22(9):2078-97. doi: 10.1097/MIB.0000000000000847.
- Background Zou Z, Wang Z. Liraglutide attenuates intestinal ischemia/reperfusion injury via NF-kappaB and PI3K/Akt pathways in mice. Life Sci. 2022 Nov 15;309:121045. doi: 10.1016/j.lfs.2022.121045. Epub 2022 Oct 4.
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- Background Madsen KB, Askov-Hansen C, Naimi RM, Brandt CF, Hartmann B, Holst JJ, Mortensen PB, Jeppesen PB. Acute effects of continuous infusions of glucagon-like peptide (GLP)-1, GLP-2 and the combination (GLP-1+GLP-2) on intestinal absorption in short bowel syndrome (SBS) patients. A placebo-controlled study. Regul Pept. 2013 Jun 10;184:30-9. doi: 10.1016/j.regpep.2013.03.025. Epub 2013 Mar 16.
- Background Hvistendahl M, Brandt CF, Tribler S, Naimi RM, Hartmann B, Holst JJ, Rehfeld JF, Hornum M, Andersen JR, Henriksen BM, Brobech Mortensen P, Jeppesen PB. Effect of Liraglutide Treatment on Jejunostomy Output in Patients With Short Bowel Syndrome: An Open-Label Pilot Study. JPEN J Parenter Enteral Nutr. 2018 Jan;42(1):112-121. doi: 10.1177/0148607116672265. Epub 2017 Dec 11.
- Background Pironi L, Arends J, Baxter J, Bozzetti F, Pelaez RB, Cuerda C, Forbes A, Gabe S, Gillanders L, Holst M, Jeppesen PB, Joly F, Kelly D, Klek S, Irtun O, Olde Damink SW, Panisic M, Rasmussen HH, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM, Shaffer J; Home Artificial Nutrition & Chronic Intestinal Failure; Acute Intestinal Failure Special Interest Groups of ESPEN. ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults. Clin Nutr. 2015 Apr;34(2):171-80. doi: 10.1016/j.clnu.2014.08.017. Epub 2014 Sep 21.
- Background Doola R, Greer RM, Hurford R, Flatley C, Forbes JM, Todd AS, Joyce CJ, Sturgess DJ. Glycaemic variability and its association with enteral and parenteral nutrition in critically ill ventilated patients. Clin Nutr. 2019 Aug;38(4):1707-1712. doi: 10.1016/j.clnu.2018.08.001. Epub 2018 Aug 16.
- Background Olveira G, Tapia MJ, Ocon J, Cabrejas-Gomez C, Ballesteros-Pomar MD, Vidal-Casariego A, Arraiza-Irigoyen C, Olivares J, Conde-Garcia MC, Garcia-Manzanares A, Botella-Romero F, Quilez-Toboso RP, Matia P, Rubio MA, Chicharro L, Burgos R, Pujante P, Ferrer M, Zugasti A, Petrina E, Manjon L, Dieguez M, Carrera MJ, Vila-Bundo A, Urgeles JR, Aragon-Valera C, Sanchez-Vilar O, Breton I, Garcia-Peris P, Munoz-Garach A, Marquez E, Del Olmo D, Pereira JL, Tous MC. Hypoglycemia in noncritically ill patients receiving total parenteral nutrition: a multicenter study. (Study group on the problem of hyperglycemia in parenteral nutrition; Nutrition area of the Spanish Society of Endocrinology and Nutrition). Nutrition. 2015 Jan;31(1):58-63. doi: 10.1016/j.nut.2014.04.023. Epub 2014 May 10.
- Background Feng Y, Barrett M, Hou Y, Yoon HK, Ochi T, Teitelbaum DH. Homeostasis alteration within small intestinal mucosa after acute enteral refeeding in total parenteral nutrition mouse model. Am J Physiol Gastrointest Liver Physiol. 2016 Feb 15;310(4):G273-84. doi: 10.1152/ajpgi.00335.2015. Epub 2015 Dec 3.
- Background Pironi L, Steiger E, Joly F, Jeppesen PB, Wanten G, Sasdelli AS, Chambrier C, Aimasso U, Mundi MS, Szczepanek K, Jukes A, Theilla M, Kunecki M, Daniels J, Serlie M, Poullenot F, Cooper SC, Rasmussen HH, Compher C, Seguy D, Crivelli A, Santarpia L, Guglielmi FW, Kozjek NR, Schneider SM, Ellegard L, Thibault R, Matras P, Matysiak K, Van Gossum A, Forbes A, Wyer N, Taus M, Virgili NM, O'Callaghan M, Chapman B, Osland E, Cuerda C, Udvarhelyi G, Jones L, Won Lee AD, Masconale L, Orlandoni P, Spaggiari C, Diez MB, Doitchinova-Simeonova M, Serralde-Zuniga AE, Olveira G, Krznaric Z, Czako L, Kekstas G, Sanz-Paris A, Jauregui MEP, Murillo AZ, Schafer E, Arends J, Suarez-Llanos JP, Youssef NN, Brillanti G, Nardi E, Lal S; Home Artificial Nutrition and Chronic Intestinal Failure Special Interest Group of ESPEN; European Society for Clinical Nutrition and Metabolism. Characteristics of adult patients with chronic intestinal failure due to short bowel syndrome: An international multicenter survey. Clin Nutr ESPEN. 2021 Oct;45:433-441. doi: 10.1016/j.clnesp.2021.07.004. Epub 2021 Jul 28.
- Background Derenski K, Catlin J, Allen L. Parenteral Nutrition Basics for the Clinician Caring for the Adult Patient. Nutr Clin Pract. 2016 Oct;31(5):578-95. doi: 10.1177/0884533616657650. Epub 2016 Jul 20.
- Background Pironi L, Cuerda C, Jeppesen PB, Joly F, Jonkers C, Krznaric Z, Lal S, Lamprecht G, Lichota M, Mundi MS, Schneider SM, Szczepanek K, Van Gossum A, Wanten G, Wheatley C, Weimann A. ESPEN guideline on chronic intestinal failure in adults - Update 2023. Clin Nutr. 2023 Oct;42(10):1940-2021. doi: 10.1016/j.clnu.2023.07.019. Epub 2023 Jul 29.
- Background Pironi L, Boeykens K, Bozzetti F, Joly F, Klek S, Lal S, Lichota M, Muhlebach S, Van Gossum A, Wanten G, Wheatley C, Bischoff SC. ESPEN practical guideline: Home parenteral nutrition. Clin Nutr. 2023 Mar;42(3):411-430. doi: 10.1016/j.clnu.2022.12.003. Epub 2023 Jan 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLP-1 Receptor Agonists | Unknown | 0.25 mg | — |