Clinical Trial: Bedtime cheese (late evening snack) intervention for nocturnal hypoglycemia after gastrectomy and comparison among surgical procedures: a prospective interventional study using continuous glucose monitoring (Japan)

Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063040) titled 'A study to examine whether eating cheese before bedtime is effective against low blood glucose during sleep after stomach surgery, and whether the degree of low blood glucose differs by type of surgery' on Sept. 24.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Kitasato University

Condition: Condition - Nocturnal hypoglycemia after gastrectomy for gastric cancer or esophagogastric junction cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - Asymptomatic nocturnal low glucose is frequently detected by continuous glucose monitoring (CGM) after gastrectomy. In our pilot study, supplementation with a low-carbohydrate, high-fat enteral formula (200 mL twice daily) reduced the time with CGM glucose below 70 mg/dL, but abdominal symptoms such as postprandial abdominal gurgling, lower abdominal bloating, and upper abdominal pain after meals worsened. In this study, patients after gastrectomy wear a CGM sensor for two weeks, and the following two questions are addressed. (1) Study 1 (observational): to compare CGM-derived nocturnal low glucose exposure (nocturnal time below range, TBR) among surgical procedures (distal, proximal, appetite-preserving, and total gastrectomy). The main comparison is between appetite-preserving gastrectomy (APG) and total gastrectomy. APG, developed in our department for esophagogastric junction cancer or upper gastric cancer confined to the lesser curvature, preserves the ghrelin-producing gastric fundus with its blood supply as an endocrine organ; food passes directly from the esophagus to the jejunum and does not pass through the preserved remnant stomach. Nocturnal TBR is compared between APG, which preserves the ghrelin-producing region, and total gastrectomy, which removes it, with adjustment for differences in patient background and postoperative course. (2) Study 2 (interventional): to test whether eating a small amount (two pieces, about 34 g) of commercially available processed cheese, which can be bought in ordinary stores, as a late evening snack improves nocturnal TBR, using a within-patient comparison in a crossover design with randomized order. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Cheese-first sequence: on days 1-7, participants eat two pieces (about 34 g; about 110 kcal, 7.0 g protein, 8.8 g fat, 0-1.2 g carbohydrate) of commercially available processed cheese (6P Cheese, Megmilk Snow Brand Co., Ltd.) every night one hour before bedtime, and on the following days 8-14 they eat no cheese (control week). CGM is worn continuously for all 14 days. Interventions/Control_2 - Control-first sequence: on days 1-7, participants eat no cheese (control week), and on the following days 8-14 they eat the same two pieces of cheese as in arm 1 every night one hour before bedtime. CGM is worn continuously for all 14 days.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Patients who meet all of the following: 1) Underwent distal, proximal, appetite-preserving, or total gastrectomy for gastric cancer (C16) or esophagogastric junction cancer (C15) 2) Three months to five years after surgery at enrollment, with stable general condition (ECOG performance status 0-1) 3) Aged 20 to 85 years at enrollment 4) Able to manage CGM wear, the symptom diary, and cheese intake independently, with written informed consent obtained from the patient Key exclusion criteria - Patients who meet any of the following: 1) Receiving pharmacological treatment for diabetes (oral hypoglycemic agents or insulin); patients managed by diet alone are not excluded 2) Currently receiving chemotherapy (patients who have completed adjuvant chemotherapy are eligible) 3) Active malignancy or recurrence (patients with no evidence of disease after treatment and no recurrence at enrollment are not excluded) 4) Severe hepatic or renal dysfunction (including dialysis) 5) Unable to eat the study food because of milk or dairy allergy or similar reasons 6) Unable to wear the CGM sensor because of skin disease, adhesive allergy, or similar reasons 7) Pregnant or breastfeeding 8) Unable to give consent or to manage the diary and cheese intake independently because of cognitive decline or similar reasons 9) After local resection or surgery for remnant gastric cancer (including reoperation with completion gastrectomy) 10) Regular use of enteral formula or other nutritional supplements that cannot be stopped during the measurement period 11) Any other condition judged inappropriate by the principal investigator or a co-investigator Target Size - 140

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 28 Day Date of IRB - 2026 Year 09 Month 16 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2029 Year 01 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072164

Disclaimer: Curated by HT Syndication.