UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056689 |
|---|---|
| Receipt number | R000064799 |
| Scientific Title | The Effect of Diet and Exercise Combination on Blood Glucose Levels in Patients with Type 1 Diabetes: N-of-1 Crossover Intervention Trial |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/14 09:28:50 |
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Basic information
Public title
Effects of diet and exercise combination on blood glucose levels in patients with type 1 diabetes.
Acronym
Diet, exercise, and blood glucose levels in type 1 diabetics
Scientific Title
The Effect of Diet and Exercise Combination on Blood Glucose Levels in Patients with Type 1 Diabetes: N-of-1 Crossover Intervention Trial
Scientific Title:Acronym
The study on Diet, Exercise, and Blood Glucose Levels in Patients with Type 1 Diabetes
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to
conduct an N-of-1 crossover intervention trial in patients with type 1 diabetes to determine the combination of diet and exercise patterns that are effective in keeping blood glucose levels within normal ranges.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
A subject consumes a high fat/low protein/low carbohydrate diet for 1 week, while performing aerobic exercise (jogging at 70% of their maximum heart rate) 1 hour after dinner on alternate days.
Interventions/Control_2
A subject consumes high fat/high protein/low carbohydrate diet for 1 week, while performing 45 minutes of resistance training 1 hour after dinner on alternate days.
Interventions/Control_3
A subject consumes low fat/low protein/high carbohydrate diet for 1 week, while performing aerobic exercise (jogging at 70% of their maximum heart rate) 1 hour after dinner on alternate days.
Interventions/Control_4
A subject consumes low fat/high protein/high carbohydrate diet for 1 week, while performing 45 minutes of resistance training 1 hour after dinner on alternate days.
Interventions/Control_5
A subject consumes a diet with balanced PFC ratio for 1 week, while performing aerobic exercise (jogging at 70% of their maximum heart rate) 1 hour after dinner on alternate days.
Interventions/Control_6
A subject consumes high fat/low protein/low carbohydrate diet for 1 week, while performing 45 minutes of resistance training 1 hour after dinner on alternate days.
Interventions/Control_7
A subject consumes high fat/high protein/low carbohydrate diet for 1 week, while performing aerobic exercise (jogging at 70% of their maximum heart rate) 1 hour after dinner on alternate days.
Interventions/Control_8
A subject consumes low fat/low protein/high carbohydrates diet for 1 week, while performing 45 minutes of resistance training 1 hour after dinner on alternate days.
Interventions/Control_9
A subject consumes low fat/high protein/high carbohydrates for 1 week, while performing aerobic exercise (jogging at 70% of their maximum heart rate) 1 hour after dinner on alternate days.
Interventions/Control_10
A subject consumes a diet with balanced PFC ratio for 1 week, while performing 45 minutes of resistance training 1 hour after dinner on alternate days.
Eligibility
Age-lower limit
| 23 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult men with type 1 diabetes who has no health problems by exercise.
Key exclusion criteria
Those with complications that contraindicate even light exercise
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429476745
tanisawa@waseda.jp
Public contact
Name of contact person
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama
TEL
0429476745
Homepage URL
tanisawa@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University, Ethics Review Committee on Research with Human Subjects
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo
Tel
0352721639
rinri@list.waseda.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 | 01 | Month | 14 | 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
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | 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 | 01 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064799
