UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008250
Receipt number R000009714
Scientific Title Visceral fat and adipocytokine profile in Japanese patients with type2 diabetes mellitus treated with DPP-4 inhibitors.
Date of disclosure of the study information 2012/07/01
Last modified on 2015/01/27 17:40:59

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Visceral fat and adipocytokine profile in Japanese patients
with type2 diabetes mellitus treated with DPP-4 inhibitors.

Acronym

DPP-4 inhibitors and visceral fat

Scientific Title

Visceral fat and adipocytokine profile in Japanese patients
with type2 diabetes mellitus treated with DPP-4 inhibitors.

Scientific Title:Acronym

DPP-4 inhibitors and visceral fat

Region

Japan


Condition

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of DPP4 inhibitors upon the profile of adipocytokines, the area of visceral fat and the ratio of visceral/subcutaneous fat area, we set up cohort prospective clinical trial in Japanese type 2 diabetes patients treated with DPP4 inhibitors.
Pioglitazone and Metformin groups were also set as a positive control and a negative control, respectively.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Decrement of visceral fat area/
visceral fat/subcutaneous fat rate,
Change in adipocytokine/PWV

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Alogliptin 25mg

Interventions/Control_2

Pioglitazone 15mg-30mg

Interventions/Control_3

Metformin 500mg-2250mg

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Type 2 diabetes patients, attending the OPD of the Division of Diabetes, Metabolism and Endocrinology, Kawasaki Medical School hospital, insufficiently controlled (HbA1c (NGSP) less than 9%) with alimentary therapy or on alpha-glucosidase inhibitors and/or sulfonylurea.

Key exclusion criteria

1) Patients who were added other OADs during the course of the trial.
2) Patients on corticodteroid.
3) Patients with renal impairment or moderate to severe hepatic dysfunction.
4) Patients with heart failure.
5) Patients treated with insulin or who absolutely needs insulin treatment.
6) Patients with current malignancy.
7) Patients with endocrine disorders.
8) Patients with severe mental illness.
9) Patients with pregnancy or lactating.
10) An excessive alcohol drunker.
11) Patients under the contraindication of each drugs.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoatsu Mune

Organization

Kawasaki Medical School Hospital

Division name

Division of Diabetes, Endocrinology and Metabolism

Zip code


Address

577 Matsushima, Kurashiki 701-0192, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Mitsuru Hashiramoto

Organization

Kawasaki Medical School Hospital

Division name

Division of Diabetes, Endocrinology and Metabolism

Zip code


Address

577 Matsushima, Kurashiki 701-0192, Japan

TEL

086-462-1111

Homepage URL


Email

hashira@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School Hospital

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

川崎医科大学附属病院 (岡山県) (Kawasaki Medical School、Okayama, Japan)


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 01 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

Per test planner retirement

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

Terminated

Date of protocol fixation

2012 Year 06 Month 20 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date

2014 Year 04 Month 01 Day

Date of closure to data entry

2014 Year 04 Month 01 Day

Date trial data considered complete

2014 Year 04 Month 01 Day

Date analysis concluded

2014 Year 04 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 06 Month 25 Day

Last modified on

2015 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009714


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name