UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022738
Receipt number R000026181
Scientific Title Effects on the improvement of blood glucose and changes in body composition of oral anti-diabetic drug SGLT2 inhibitor.~ Relevance to the compliance of the diet therapy for diabetes~
Date of disclosure of the study information 2016/06/14
Last modified on 2018/02/02 09:41:35

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Basic information

Public title

Effects on the improvement of blood glucose and changes in body composition of oral anti-diabetic drug SGLT2 inhibitor.~ Relevance to the compliance of the diet therapy for diabetes~

Acronym

Effect of SGLT2 inhibitor and diet therapy

Scientific Title

Effects on the improvement of blood glucose and changes in body composition of oral anti-diabetic drug SGLT2 inhibitor.~ Relevance to the compliance of the diet therapy for diabetes~

Scientific Title:Acronym

Effect of SGLT2 inhibitor and diet therapy

Region

Japan


Condition

Condition

Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The SGLT2 inhibitor which is an oral medicine for diabetes exerts the blood glucose lowering effect by promoting urinary glucose excretion. The aim of this study is to clarify the effect of the improvement of blood glucose levels, the influence for the changing of body composition including body weight and muscle weight. In addition, we focus on the adherence to the diet therapy for diabetes, and determine the factors of the difference of the showing effect of SGLT2 inhibitor in the patients who show the effectiveness or non-effectiveness.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Amount of Parameters of blood glucose (HbA1c, fasting blood glucose, glycoalbumin, insulin,CPR)

Key secondary outcomes

1)Amount of change in Body weight
2)Amount of change in Body composition (fat, muscle etc.)
3)Carbohydrate intake
4)Urinary albumin excretion
5)eGFRcreat (calculation by conversion formula of GFRcreat in Japanese),
serum creatinine
6)Urinary L-FABP excretion, serum cystatinC (Cys-C), eGFRcys (calculation by conversion formula of eGFRcys in Japanese)
7)Serum lipid (T-cho, LDL, HDL, TG)
8)Blood pressure, pulse
9)Liver function(AST,ALT,gammaGTP)
10)Uric acid
11)Hematocrit
12)Ketone Body,Lactic acid
13)BDHQ: intake of energy, protein, lipid and dietary fiber, nutritional education


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

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Outpatients and hospitalized patients in the department of endocrinology and metabolism of Kanazawa Medical University Hospital.
The diabetic patiens who have the adaptation for the treatment of SGLT2 inhibitor that was judged by the physician (>=20 and<=80 of age)

Key exclusion criteria

None

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Koya

Organization

Kanazawa Medical University

Division name

Diabetology and Endocrinology

Zip code


Address

1-1Daigaku,Uchinada,Kahoku-gun, Ishikawa Prefecture, 920-0293

TEL

076-286-2211

Email

koya0516@kanazawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuka Kuroshima

Organization

Kanazawa Medical University

Division name

Diabetology and Endocrinology

Zip code


Address

1-1Daigaku,Uchinada,Kahoku-gun, Ishikawa Prefecture, 920-0293

TEL

076-286-2211

Homepage URL


Email

naipicrc@kanazawa-med.ac.jp


Sponsor or person

Institute

Kanazawa Medical University

Institute

Department

Personal name



Funding Source

Organization

None

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


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 06 Month 14 Day


Related information

URL releasing protocol


Publication of results

Published


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

2015 Year 05 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 06 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We clarify the effect of the improvement of blood glucose levels, the influence for the changing of body composition including body weight and muscle weight. In addition, we focus on the adherence to the diet therapy for diabetes, and determine the factors of the difference of the showing effect of SGLT2 inhibitor in the patients who show the effectiveness or non-effectiveness.


Management information

Registered date

2016 Year 06 Month 14 Day

Last modified on

2018 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026181


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name