UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056491 |
|---|---|
| Receipt number | R000064556 |
| Scientific Title | A Randomized Controlled Trial of the Effect of Body-Weight-Based HIIT (High Intensity Interval Exercise) on Insulin Resistance in Patients with Type 2 Diabetes Mellitus |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2024/12/18 14:54:30 |
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Basic information
Public title
Effect of HIIT (High Intensity Interval Exercise) on Insulin Resistance in Type 2 Diabetics
Acronym
Effect of HIIT on Insulin Resistance in Type 2 Diabetics
Scientific Title
A Randomized Controlled Trial of the Effect of Body-Weight-Based HIIT (High Intensity Interval Exercise) on Insulin Resistance in Patients with Type 2 Diabetes Mellitus
Scientific Title:Acronym
A Randomized Controlled Trial of the Effect of Body-Weight-Based HIIT on Insulin Resistance 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 examine the effect of weight-bearing exercise-based HIIT on insulin resistance in patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insulin resistance (HOMA-IR)
Key secondary outcomes
Fasting insulin, fasting blood glucose, heart rate, blood pressure, 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
high-intensity interval training
Interventions/Control_2
Walking
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 diagnosed with type 2 diabetes mellitus, not on insulin therapy, and fasting blood glucose level less than 140 mg/dL, and those who do not have an exercise habit (at least twice a week for at least 30 minutes each time).
Key exclusion criteria
a person who is unable to perform HIIT due to a musculoskeletal disorder, a person who is restricted from exercising by his/her physician, a person who has a urine ketone body positive and blood glucose level of 250 mg/dL or higher, a person with pre proliferative retinopathy or higher, a person with over manifest nephropathy (eGFR < 30 mL/min/1.73 m2 or urine albumin level > 300 mg/gCr or urinary protein level of 0.5 g/gCr or higher), ischemic heart disease or cardiopulmonary impairment, uncontrolled hypertension (180/110 mmHg or higher), dyslipidemia (LDL cholesterol level of 140 mg/dL or higher, HDL cholesterol level of less than 40 mg/dL, triglyceride level of less than 40 mg/gCr or higher), and other conditions. HDL cholesterol level less than 40 mg/dL, triglyceride level more than 150 mg/dL), and those with a family history of cardiovascular disease or smoking history.
Target sample size
28
Research contact person
Name of lead principal investigator
| 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
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
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences, Health Ethics Audit 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 | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 14 | 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=R000064556
