UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041219 |
|---|---|
| Receipt number | R000047076 |
| Scientific Title | The assessment of glycemic excrusion using continuous glucose monitoring in postoperative gastric cancer patients. |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2024/07/30 10:30:16 |
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Basic information
Public title
The assessment of glycemic excrusion using continuous glucose monitoring in postoperative gastric cancer patients.
Acronym
The assessment of glycemic excrusion using continuous glucose monitoring in postoperative gastric cancer patients.
Scientific Title
The assessment of glycemic excrusion using continuous glucose monitoring in postoperative gastric cancer patients.
Scientific Title:Acronym
The assessment of glycemic excrusion using continuous glucose monitoring in postoperative gastric cancer patients.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the glycemic excrusion after meal or oral nutritional supplements for patients undergoing gastrectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve between five days using the CGM
Key secondary outcomes
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
We use the CGM between five days, after patients undergoing gastrectomy can eat rice porridge.
In the third day, we add 200calories nutritional supplements.
In the fourth day, we add 400calories nutritional supplements.
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
1.Able to ingest food orally
2.Scheduled to receive curative gastrectomy
3.patients with consent after full explanation and understanding of our stud
Key exclusion criteria
1.diabetic patients(HbA1c:more than 6)
2.allergic patients for dairy product or gelatin
3.patients with non-curative resection
4.patients with visual impairment without caregivers
5.patients judged to be inappropriate by the doctor
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Hatao |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
fchobi@gmail.com
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Hatao |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
183-8524
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
fchobi@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Tama Medical Center
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
Tel
042-323-5111
tamarinshou@tmhp.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
| 2020 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s00595-022-02600-w
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s00595-022-02600-w
Number of participants that the trial has enrolled
17
Results
Results
The AUC < 70 did not differ significantly with or without SED ONS over the observation period. SED ONS did not cause postprandial hypoglycemia and prevented nocturnal hypoglycemia. The mean dietary intake did not change significantly during the observation period, and the total energy intake increased significantly according to the amount of SED ONS provided.
Conclusion
SED ONS after gastrectomy increased the total energy intake without dietary reduction and it did not result in hypoglycemia.
Results date posted
| 2024 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria
1.Age 20 years old or older
2.Ability to ingest food orally
3.Scheduled conventional curative gastrectomy for gastric cancer
Exclusion criteria
1.Current treatment for diabetes
2.Scheduled function-preserving gastrectomy, such as pylorus-preserving gastrectomy, or proximal gastrectomy
3.Allergy to milk or gelatin components
4.Visual impairment with no care giver
Participant flow
Curative gastrectomy for gastric cancer was performed at the study center. The surgeons chose the surgical approach and reconstructive method according to their experience. For distal gastrectomy (DG) they performed Billroth I (DG-BI) or Roux-en-Y reconstruction (DG-RY) and for total gastrectomy (TG), they performed Roux-en-Y reconstruction.
Adverse events
None
Outcome measures
The primary outcome was the area under the curve < glucose 70 mg/dL (AUC < 70). The secondary outcomes were other indices of glucose fluctuation and the amount of food and SED ONS intake.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2023 | Year | 03 | 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
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047076
