UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052178 |
|---|---|
| Receipt number | R000059434 |
| Scientific Title | The effect of moderate intensity exercise on postprandial hyperglycemia in prediabetes: Integrated monitoring by physical activity monitor, application for meals and continuous glucose monitoring |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2023/09/11 05:48:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of post-meal exercise on postprandial hyperglycemia in prediabetes: Integrated monitoring by physical activity monitor, application for diet therapy and continuous glucose monitoring
Acronym
Improvement of post-prandial hyperglycemia by exercise immediately afeter meals in prediabetes: integrated monitoring of physical activity, meals and interstitial glucose
Scientific Title
The effect of moderate intensity exercise on postprandial hyperglycemia in prediabetes: Integrated monitoring by physical activity monitor, application for meals and continuous glucose monitoring
Scientific Title:Acronym
Improvement of post-prandial hyperglycemia by exercise immediately after meals in prediabetes: integrated monitoring of physical activity, meals and interstitial glucose
Region
| Japan |
Condition
Condition
prediabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
People with prediabetes is associated with increased risk of type 2 diabetes and cardiovascular events. We make plan to evaluate the effects of moderate intensity walking done immediately after meals for postprandial hyperglycemia with prediabetes by continuous glucose monitoring (Freestyle Libre) for 14 days. Participants use Fitbit as activity monitor to keep intensity of walking and manage meals with application for diet therapy. We will compare profiles of blood glucose of initial five days without exercise and after five days with exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial blood glucose profiles with and without post meal exercise. AUC of blood glucose between start of eating and four hours after first bite, RCMC after eating, TIR and TAR with exercise and without exercise.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
30 minutes moderate intensity walking immediately after lunch.
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
Male adults with prediabetes
Key exclusion criteria
Diabetes
Cardiovascular diseases
Taking beta blocker
Serious hypertension
Unable to exercise with extreme obesity.
Skin allergy
Unable to use smartphone.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsumi |
| Middle name | |
| Last name | Yoshihito |
Organization
Eiju General Hospital
Division name
Diabetes Center
Zip code
110-8645
Address
23-16, 2chome, Higashi-Ueno, Taito-ku, Tokyo Japan
TEL
03-3833-8381
yoshihito.atsumi@eijuhp.com
Public contact
Name of contact person
| 1st name | Koide |
| Middle name | |
| Last name | Keiko |
Organization
Eiju General Hospital
Division name
Diabetes Center
Zip code
110-8645
Address
23-16, 2chome, Higashi-Ueno, Taito-ku, Tokyo Japan
TEL
03-3833-8381
Homepage URL
kessworld@outlook.jp
Sponsor or person
Institute
Eiju General Hospital, Diabetes Center
Institute
Department
Personal name
atsumi yoshihito
Funding Source
Organization
NSD co.LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Eiju General Hospital
Address
23-16, 2chome, Higashi-Ueno, Taito-ku, Tokyo Japan
Tel
0338338381
yoshihito.atsumi@eijuhp.com
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
| 2023 | Year | 09 | Month | 20 | 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
| 2023 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059434
