UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020923
Receipt number R000024106
Scientific Title Effect of the SGLT2 inhibitor on basal energy expenditure in type 2 diabates mellitus
Date of disclosure of the study information 2016/02/08
Last modified on 2018/08/12 18:21:24

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Basic information

Public title

Effect of the SGLT2 inhibitor on basal energy expenditure in type 2 diabates mellitus

Acronym

SGLT2 inhibitor intervention study

Scientific Title

Effect of the SGLT2 inhibitor on basal energy expenditure in type 2 diabates mellitus

Scientific Title:Acronym

SGLT2 inhibitor intervention study

Region

Japan


Condition

Condition

type 2 diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We examine the influence of SGLT2 inhibitor on resting energy expenditure in type 2 diabetes mellitus.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

resting energy expenditure of three months after taking medicine

Key secondary outcomes

body weight, respiration quotient and HbA1c of three months after taking medicine


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

Interventions/Control_1

The patient takes medicine with SGLT2 inhibitor of three months.
We prescribe only Empagliflozin in this study.
The dosage depends on therapy.

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

30 years-old <=

Age-upper limit

84 years-old >=

Gender

Male and Female

Key inclusion criteria

patients with type 2 diabetes mellitus

Key exclusion criteria

A patient with much active mass (exercise) in everyday life
A patient with after the third diabetic nephropathy
A patient with liver function abnormality
85 years or older

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eitaro Nakashima

Organization

Chubu Rosai Hospital, Japan Labour Health and Welfare Organization

Division name

DiaDiabetes & Endocrinology, Diabetes Center

Zip code


Address

1-10-6 Koumei Minato-ku Nagoya

TEL

052-652-5511

Email

eitaro@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Eitaro Nakashima

Organization

Chubu Rosai Hospital, Japan Labour Health and Welfare Organization

Division name

DiaDiabetes & Endocrinology, Diabetes Center

Zip code


Address

1-10-6 Koumei Minato-ku Nagoya

TEL

052-652-5511

Homepage URL


Email

eitaro@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University of Arts and Sciences

Institute

Department

Personal name



Funding Source

Organization

Nagoya University of Arts and Sciences

Organization

Division

Category of Funding Organization

Other

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

2016 Year 02 Month 08 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

REE showed a decreasing trend of 1554(SD257)kcal/day and 1491(SD313)kcal/day before and after administration of SGLT 2 inhibitor, respectively, but it was not significant.
In addition, there was no significant difference in REE per body weight. Body weight and body fat mass decreased significantly, but skeletal muscle mass did not change significantly.
In conclusion, it was suggested that taking SGLT 2 inhibitor for 3 months may not affect REE.

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

2016 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 25 Day

Last follow-up date

2017 Year 12 Month 01 Day

Date of closure to data entry

2017 Year 12 Month 01 Day

Date trial data considered complete

2018 Year 03 Month 20 Day

Date analysis concluded

2018 Year 03 Month 20 Day


Other

Other related information



Management information

Registered date

2016 Year 02 Month 08 Day

Last modified on

2018 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024106


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name