UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018452 |
|---|---|
| Receipt number | 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 17:52:48 |
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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
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
sanoyama@nms.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Nippon Medical School, Tokyo, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021231
