UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive values of changes in body composition in type 2 diabetes patients under intensive treatment.
Title of the study (Brief title)	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	Isao Minami
Organization	Tokyo Medical and Dental University
Division name	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5216
Email	iminami.mem@tmd.ac.jp

Public contact
Name of contact person	Isao Minami
Organization	Tokyo Medical and Dental University
Division name	Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5216
Homepage URL
Email	iminami.mem@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028085