UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024401 |
|---|---|
| Receipt number | R000028085 |
| Scientific Title | Predictive values of changes in body composition in type 2 diabetes patients under intensive treatment. |
| Date of disclosure of the study information | 2016/10/13 |
| Last modified on | 2016/10/13 21:34:32 |
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Basic information
Public title
Predictive values of changes in body composition in type 2 diabetes patients under intensive treatment.
Acronym
Changes in body composition during diabetes care
Scientific Title
Predictive values of changes in body composition in type 2 diabetes patients under intensive treatment.
Scientific Title:Acronym
Changes in body composition during diabetes care
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Weight loss, which is effective for reducing visceral fat, may cause concomitant loss of skeletal muscle mass. The aim of this study is to elucidate the predictors of changes in visceral fat and skeletal muscle mass in response to intensive diabetes treatment including weight reduction.
Basic objectives2
Others
Basic objectives -Others
Association between changes in body weight and changes in body composition
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in appendicular lean soft tissue mass during intensive diabetes treatment for six months
Key secondary outcomes
Changes in visceral fat area during intensive diabetes treatment for six months
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
All patients received intensive medical therapy and lifestyle modification, including caloric restriction and regular exercise. The components of lifestyle guidance individually varied according to the plan discussed between the patient, dietician, and physician. Briefly, patients were instructed to restrict daily caloric intake under 25-30kcal per ideal body weight and to exercise 30 minutes or more at least three times a week.
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes who were hospitalized at Tokyo Medical and Dental University Hospital for glycemic control.
Key exclusion criteria
Patients with severe renal impairment, defined as having an estimated glomerular filtration rate (eGFR) of < 15 mL/min/1.73 m2 or undergoing renal replacement therapy, and those with severe infection or serious trauma.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Minami |
Organization
Tokyo Medical and Dental University
Division name
Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5216
iminami.mem@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Minami |
Organization
Tokyo Medical and Dental University
Division name
Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5216
Homepage URL
iminami.mem@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 10 | Month | 13 | 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
| 2013 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 08 | 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
| 2016 | Year | 10 | Month | 13 | Day |
Last modified on
| 2016 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028085
