UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024827 |
|---|---|
| Receipt number | R000028196 |
| Scientific Title | A Study for energy requirement and metabolic adaptation to dietary intakes and exercise in subjects with type two diabetes mellitus |
| Date of disclosure of the study information | 2016/11/21 |
| Last modified on | 2024/05/25 05:39:27 |
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Basic information
Public title
A Study for energy requirement and metabolic adaptation to dietary intakes and exercise in subjects with type two diabetes mellitus
Acronym
Energy requirement and metabolic adaptation in subjects with type two diabetes mellitus
Scientific Title
A Study for energy requirement and metabolic adaptation to dietary intakes and exercise in subjects with type two diabetes mellitus
Scientific Title:Acronym
Energy requirement and metabolic adaptation in subjects with type two diabetes mellitus
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine matabolic adaptation to meal ingestion and exercise load in normal weight subjects with impaired glucose tolerance
Basic objectives2
Others
Basic objectives -Others
To examine relationships between daily physical activity or nutritional status and matabolic adaptation in normal weight subjects with impaired glucose tolerance
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of respiratory quotient during meal ingestion and exercise load
Key secondary outcomes
Total energy expenditure, daily physical activity, body composition, nutritional status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Subjects: Healthy normal weight subject
Acute meal ingestion and exercise load
Meal ingestion: 600 kcal of total energy intakes, P:F:C ratio is 15:50:35
Exercise load: 20-min moderate-intensity exercise by a cycle ergometer
Interventions/Control_2
Subjects: Normal weight subject with impaired fasting glucose
Acute meal ingestion and exercise load
Meal ingestion: 600 kcal of total energy intakes, P:F:C ratio is 15:50:35
Exercise load: 20-min moderate-intensity exercise by a cycle ergometer
Interventions/Control_3
Subjects: Normal weight subject with type 2 diabetes melllitus
Acute meal ingestion and exercise load
Meal ingestion: 600 kcal of total energy intakes, P:F:C ratio is 15:50:35
Exercise load: 20-min moderate-intensity exercise by a cycle ergometer
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy normal weight subject OR normal weight subject with impaired fasting glucose OR normal weight subject with type 2 diabetes melllitus
Normal weight: Body mass index 20-25kg/m2
Impaired fasting glucose: fasting glucose concentration 110mg/dL-126mg/dL
Type 2 diabetes melllitus is defiend by a criteria according to the guideline by the Japan diabetes society
2)A subject can perform 20-min moderate-intensty exercise
Key exclusion criteria
1) Excessive body weight fluctuation (5%) during 3 months before an expriment
2) A subject shall not have present history of the disease or anamnesis as follows: Cerebrovascular disorder, heart disease, High blood pressure (grade3)
3) A subject shall not take medicine effecting to energy metabolism or water metabolism, including fibrate-based medicines, bata blocker, diuretic, insulin, GLP-1 analogue, or SGLT2 inhibitors
4) A subject shall not present have history of the disease effecting to energy metabolism or water metabolism
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
National Institute of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutritional Science
Zip code
5660002
Address
Kento Inovationpark NK building, 3-17 Shinmachi Senrigaoka, Settsu City, Osaka
TEL
06-6384-1120
kt207460@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Ishikawa-Takata |
Organization
National Institute of Biomedical Innovation, Health and Nutrition
Division name
Department of Nutritional Science
Zip code
5660002
Address
Kento Inovationpark NK building, 3-17 Shinmachi Senrigaoka, Settsu City, Osaka
TEL
06-6384-1120
Homepage URL
kt207460@nodai.ac.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
TOBE MAKI Scholarship Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Asagi Saito Barakishi, Ohsaka
Tel
072-641-9829
irb-office@nibiohn.go.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
| 2016 | Year | 11 | Month | 21 | 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
17
Results
under analysis
Results date posted
| 2019 | Year | 11 | Month | 19 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
asking re-agreement, because of insufficient protocol
Date of the first journal publication of results
Baseline Characteristics
40 to 70 years old men with BMI of 20 to 25kg/m2, With or without type 2 diabetes.
Participant flow
Patients were asked through hospitals, and healthy controls were recruited voluntary.
Adverse events
none
Outcome measures
metabolic flexibility
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028196
