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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018452
Receipt No. R000021231
Scientific Title The role of diet-induced thermogenesis for dietary intervention in type 2 diabetes
Date of disclosure of the study information 2015/07/29
Last modified on 2015/07/28

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Basic information
Public title The role of diet-induced thermogenesis for dietary intervention in type 2 diabetes
Acronym Energy expenditure in type 2 diabetes
Scientific Title The role of diet-induced thermogenesis for dietary intervention in type 2 diabetes
Scientific Title:Acronym Energy expenditure in type 2 diabetes
Region
Japan

Condition
Condition Patients with type 2 diabetes who were admitted to Nippon Medical School Hospital (Tokyo, Japan) for glycemic control
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the determinants for the efficacy of dietary intervention in type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes energy expenditure (EE) was evaluated at fasting (REE) and postprandial (PPEE) state using an indirect calorimeter, and difference between REE and PPEE was calculated.
Weight reduction rate during the hospitalization.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes
Key exclusion criteria xclusion criteria included receiving insulin therapy before hospitalization, proliferative diabetic retinopathy, diabetic nephropathy stage 3 or higher , ketoacidosis, liver cirrhosis, uncontrolled endocrine diseases, infectious disease, malignant disease, and other systemic diseases.
Target sample size

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Sugihara
Organization Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL 03-3822-2131
Email hitoshi@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Sanoyama
Organization Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
Division name Department of Endocrinology, Diabetes and Metabolism
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL 03-3822-2131
Homepage URL
Email sanoyama@nms.ac.jp

Sponsor
Institute Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
Institute
Department

Funding Source
Organization Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
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
Address
Tel
Email

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
2015 Year 07 Month 29 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 Completed
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2015 Year 07 Month 28 Day
Last modified on
2015 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021231

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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