UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056490 |
|---|---|
| Receipt number | R000064553 |
| Scientific Title | A Randomized Controlled Trial of the Effect of Pre-meal Weight-Based High-Intensity Interval Training (HIIT) on Postprandial Glucose Concentrations in Patients with Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2024/12/18 14:13:18 |
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Basic information
Public title
Effect of High Intensity Interval Training (HIIT) Performed Before Meals on Postprandial Glucose Concentrations.
Acronym
Effect of HIIT Performed Before Meals on Postprandial Glucose Concentrations.
Scientific Title
A Randomized Controlled Trial of the Effect of Pre-meal Weight-Based High-Intensity Interval Training (HIIT) on Postprandial Glucose Concentrations in Patients with Type 2 Diabetes Mellitus
Scientific Title:Acronym
A Randomized Controlled Trial of the Effect of Pre-meal Weight-Based HIIT on Postprandial Glucose Concentrations in Patients with Type 2 Diabetes Mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of high-intensity interval training performed on type 2 diabetics on postprandial glucose concentrations compared to pedaling exercise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incremental area under the postprandial glucose concentration curve (iAUC)
Key secondary outcomes
Peak postprandial glucose concentration, blood pressure, heart rate, cardiac parasympathetic nervous system activity, enjoyment of exercise (PACES), subjective exercise intensity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Pre-meal high-intensity interval training
Interventions/Control_2
Pre-meal pedaling exercise
Interventions/Control_3
No special physical activity (control)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have been diagnosed with type 2 diabetes and have not been restricted from high-intensity interval training by their physicians.
Key exclusion criteria
The most recently measured HbA1c is 8.5% or higher, the patient is on insulin therapy, the fasting blood glucose level is 250 ml/dl or higher or urine ketone level is moderately positive or higher, the patient has proliferative preretinopathy or renal failure, the patient has ischemic heart disease or cardiopulmonary function impairment.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Ono |
| Middle name | |
| Last name | Kumiko |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, Japan
TEL
078-792-2555
onoku@tiger.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Ono |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, Japan
TEL
078-792-2555
Homepage URL
onoku@tiger.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
JST SPRING,Grant Number JPMJSP2148
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hayashi clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences Health Sciences Ethics Review Committee
Address
7-10-2 Tomogaoka, Suma, Kobe, Hyogo, Japan
Tel
078-796-4502
syomu2@ams.kobe-u.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
林医院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064553
