UMIN-CTR Clinical Trial

Public title

The observational study to search for the predictors of the changes of body weight and composition by intensive lifestyle modification for the patients with metabolic syndrome

Acronym

The predictors of the changes of body weight and composition

Scientific Title

The observational study to search for the predictors of the changes of body weight and composition by intensive lifestyle modification for the patients with metabolic syndrome

Scientific Title:Acronym

The predictors of the changes of body weight and composition

Region

Japan

Condition

Type 2 diabetes and obesity patients

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the pattern of the changes of body composition by intensive lifestyle modification for the patients with type 2 diabetes or obesity

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The changes of body weight, appendicular lean soft tissue mass and body fat percentage during 6 months follow-up.

Key secondary outcomes

The changes of visceral and subctaneous fat area during 6 months follow-up.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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 calorie restriction and regular exercise. The content of lifestyle guidance was varied individually during hospitalization based on consultation between the patient, a dietician, and a physician. Briefly, patients were instructed to restrict daily calorie intake under 25-30kcal per ideal body weight and to exercise 30 minutes or more at least three times a week. Indication of all medical therapies were decided by the attending physician of each participant following the guideline, published and coordinated by Japan Diabetes Society. After discharge, participants continued to receive medical therapy and lifestyle guidance at the hospital as an outpatient.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with type 2 diabetes or obesity who were hospitalized in Tokyo Medical and Dental University Hospital for the purpose of glycemic control or weight reduction.

Key exclusion criteria

Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 15 mL/min/1.73 m2 or undergoing renal replacement therapy), pregnant women, and those with infectious or malignant diseases were excluded.

Target sample size

150

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 Metablism

Zip code

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-6111

Email

iminami.mem@tmd.ac.jp

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 Metablism

Zip code

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-6111

Homepage URL

Email

iminami.mem@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

02

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2016

Year

02

Month

29

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

02

Month

29

Day

Last modified on

2018

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024518