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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024827
Receipt No. 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 2019/05/20

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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 Institutes of Biomedical Innovation, Health and Nutrition
Division name Department of Nutrition and metabolism
Zip code 1628636
Address 1-23-1 Toyama, Shinjuku, Tokyo, JAPAN
TEL 03-3203-5603
Email kazu@nibiohn.go.jp

Public contact
Name of contact person
1st name Kazuko
Middle name
Last name Ishikawa-Takata
Organization National Institutes Biomedical Innovation, Health and Nutrition
Division name Department of Nutrition and Metabolism
Zip code 1628636
Address 1-23-1 Toyama, Shinjuku, Tokyo JAPAN
TEL 03-3203-5603
Homepage URL
Email kazu@nibiohn.go.jp

Sponsor
Institute National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

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
Email 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
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 No longer recruiting
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
2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 14 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028196

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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