UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059293 |
|---|---|
| Receipt number | R000067822 |
| Scientific Title | Analysis of Postoperative Glycemic Variability and Dumping Syndrome According to Gastrectomy Procedures |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/10/05 15:28:44 |
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Basic information
Public title
Analysis of Postoperative Glycemic Variability and Dumping Syndrome According to Gastrectomy Procedures
Acronym
Analysis of Postoperative Glycemic Variability and Dumping Syndrome According to Gastrectomy Procedures
Scientific Title
Analysis of Postoperative Glycemic Variability and Dumping Syndrome According to Gastrectomy Procedures
Scientific Title:Acronym
Analysis of Postoperative Glycemic Variability and Dumping Syndrome According to Gastrectomy Procedures
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose fluctuations measured using a continuous glucose monitoring device.
It will be evaluated at one year postoperatively.
Key secondary outcomes
Patient background (age, sex, stage, PS, comorbidities), surgical outcomes (surgical procedure, blood loss, operating time, postoperative hospital stay, postoperative complications), adjuvant therapy, pathological diagnosis, weight change, blood test data changes (serum albumin, total cholesterol, lymphocyte count, etc.), symptom score based on PGSAS.
Blood tests, blood draws, and PGSAS questionnaires will be evaluated at the one-year postoperative mark, similar to blood glucose measurements.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous glucose monitor
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Yoshizawa |
Organization
Saitama medical university international medical center
Division name
Digestive surgery
Zip code
350-1298
Address
1397-1, Yamane Hidaka city Saitama Japan
TEL
042-984-4111
my44891@5931.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Yoshizawa |
Organization
Saitama medical university international medical center
Division name
Digestive surgery
Zip code
350-1298
Address
1397-1, Yamane Hidaka city Saitama Japan
TEL
042-984-4441
Homepage URL
my44891@5931.saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university international medical center
Institute
Department
Personal name
Funding Source
Organization
saitama medical university international medical center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical university international medical center IRB
Address
1397-1 Yamane Hidaka city Saitama Japan
Tel
042-984-4441
chikens@saitama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067822
