Unique ID issued by UMIN | UMIN000008250 |
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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 |
Visceral fat and adipocytokine profile in Japanese patients
with type2 diabetes mellitus treated with DPP-4 inhibitors.
DPP-4 inhibitors and visceral fat
Visceral fat and adipocytokine profile in Japanese patients
with type2 diabetes mellitus treated with DPP-4 inhibitors.
DPP-4 inhibitors and visceral fat
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Exploratory
Not applicable
Decrement of visceral fat area/
visceral fat/subcutaneous fat rate,
Change in adipocytokine/PWV
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
3
Treatment
Medicine |
Alogliptin 25mg
Pioglitazone 15mg-30mg
Metformin 500mg-2250mg
30 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
50
1st name | |
Middle name | |
Last name | Tomoatsu Mune |
Kawasaki Medical School Hospital
Division of Diabetes, Endocrinology and Metabolism
577 Matsushima, Kurashiki 701-0192, Japan
1st name | |
Middle name | |
Last name | Mitsuru Hashiramoto |
Kawasaki Medical School Hospital
Division of Diabetes, Endocrinology and Metabolism
577 Matsushima, Kurashiki 701-0192, Japan
086-462-1111
hashira@med.kawasaki-m.ac.jp
Kawasaki Medical School Hospital
None
Self funding
NO
川崎医科大学附属病院 (岡山県) (Kawasaki Medical School、Okayama, Japan)
2012 | Year | 07 | Month | 01 | Day |
Unpublished
Per test planner retirement
Terminated
2012 | Year | 06 | Month | 20 | Day |
2012 | Year | 08 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2012 | Year | 06 | Month | 25 | Day |
2015 | Year | 01 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009714
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