Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059293) titled 'Analysis of Postoperative Glycemic Variability and Dumping Syndrome According to Gastrectomy Procedures' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Saitama medical university international medical center

Condition: Condition - Gastric Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Various sequelae associated with reconstruction are known to occur after gastrectomy, with dumping syndrome being a representative example. Late dumping syndrome, in particular, appears 2 to 3 hours after eating. It causes rapid hyperglycemia due to accelerated gastric emptying, and excessive insulin secretion in response to this triggers reactive hypoglycemia. This results in autonomic symptoms such as sweating, palpitations, facial flushing, and tremors. Although the relationship between these blood glucose fluctuations and dumping symptoms has long been recognized, it has historically been difficult to precisely track the temporal progression of blood glucose levels.In recent years, the development of non-invasive Continuous Glucose Monitoring (CGM) devices has enabled continuous, high-frequency monitoring of blood glucose fluctuations during daily life. CGM is a relatively low-burden tool and is currently advancing in clinical applications, primarily for self-management by diabetes patients. Studies using CGM to assess post-gastrectomy glucose fluctuations have also become increasingly common.This study aims to use CGM to clarify differences in postoperative glucose dynamics and dumping symptoms according to surgical procedure (pyloric gastrectomy, total gastrectomy, and supra-pyloric gastrectomy). By providing insights that may contribute to the development of future therapeutic interventions and inform surgical procedure selection, we aim to improve the long-term quality of life (QOL) of patients after gastrectomy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous glucose monitor

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients diagnosed with primary gastric cancer Patients who underwent either pyloric gastrectomy, total gastrectomy, or cardia gastrectomy at our hospital Patients aged 20 years or older at the time of consent acquisition Patients who provided written consent to participate in this study Key exclusion criteria - Patients taking oral hypoglycemic agents or insulin on a regular basis Patients experiencing severe complications or side effects from surgery or adjuvant chemotherapy Patients with severe hepatic impairment Patients with severe renal impairment Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 01 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067822

Disclaimer: Curated by HT Syndication.