Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.
NCT ID: NCT07297238
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2026-01-01
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental arm
Participants received semaglutide as a subcutaneous injection (dosage form) at a dose of 0.25 mg (dosage) once weekly (frequency) for 28 days (duration).
GLP-1 Receptor Agonists
GLP-1 receptor agonists (semaglutide) are medications that mimic the action of the native human hormone glucagon-like peptide-1 (GLP-1). The recommended dosage is 0.25 mg administered subcutaneously once weekly.
Control arm
received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy
No interventions assigned to this group
Interventions
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GLP-1 Receptor Agonists
GLP-1 receptor agonists (semaglutide) are medications that mimic the action of the native human hormone glucagon-like peptide-1 (GLP-1). The recommended dosage is 0.25 mg administered subcutaneously once weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 80 years, inclusive, regardless of gender;
* With stable vital signs;
* Diagnosis of SBS-IF, confirmed by existing medical/surgical records, receiving parenteral nutrition (PN) due to surgical resection of the small intestine (\<200 cm from the duodenojejunal flexure), and meeting one of the following criteria:
* Colon continuity maintained without jejunal/ileal stoma (Type II or III);
* Presence of a jejunostomy or ileostomy (Type I);
* Expected requirement of PN for more than 4 weeks, with an average PN caloric intake ≥80%;
* Ability to comply with the medication dosing and visit schedule;
* Capacity to accurately describe symptoms, absence of severe infections or respiratory insufficiency, and willingness to cooperate proactively;
* No history of allergic diseases, non-allergic constitution, and no hypersensitivity to any component of semaglutide injection;
* No history of drug abuse;
* Not pregnant or lactating; no pregnancy plans within one month after the trial (applies to both female and male participants);
* No participation in any other drug trials (including the investigational product in this study) within three months prior to enrollment.
* Poor general condition, inability to accurately describe symptoms, presence of severe infection, respiratory insufficiency, or other conditions that may hinder active cooperation;
* History of allergic diseases, allergic constitution, or hypersensitivity to drugs structurally related to the investigational product;
* Patients with malignancy at any site;
* Those with psychiatric disorders, inability to cooperate, or impaired consciousness;
* Patients with contraindications to the investigational drug (including personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2);
* Immunodeficiency, or current use of immunosuppressants or corticosteroids;
* Immediate family members of the sponsor, investigator, or study staff directly involved in the trial;
* Any other condition considered by the investigator as grounds for exclusion.
18 Years
80 Years
ALL
No
Sponsors
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Jinling Hospital, China
OTHER
Responsible Party
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Wang Xinying
Prof
Principal Investigators
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Xinying Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Jinling Hospital, China
Locations
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Jinling Hospital
Nanning, China, China
Countries
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Central Contacts
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References
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Kissow H, Hartmann B, Holst JJ, Poulsen SS. Glucagon-like peptide-1 as a treatment for chemotherapy-induced mucositis. Gut. 2013 Dec;62(12):1724-33. doi: 10.1136/gutjnl-2012-303280. Epub 2012 Oct 20.
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.
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.
Thazhath SS, Marathe CS, Wu T, Chang J, Khoo J, Kuo P, Checklin HL, Bound MJ, Rigda RS, Crouch B, Jones KL, Horowitz M, Rayner CK. The Glucagon-Like Peptide 1 Receptor Agonist Exenatide Inhibits Small Intestinal Motility, Flow, Transit, and Absorption of Glucose in Healthy Subjects and Patients With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes. 2016 Jan;65(1):269-75. doi: 10.2337/db15-0893. Epub 2015 Oct 15.
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.
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.
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.
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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.
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.
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.
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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.
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Other Identifiers
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2025-09-17
Identifier Type: -
Identifier Source: org_study_id