Unique ID issued by UMIN | UMIN000005013 |
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Receipt number | R000005961 |
Scientific Title | Okayama prospective oBservational study for the Effect by Sitagliptin on obesE type2 diabetes |
Date of disclosure of the study information | 2011/02/04 |
Last modified on | 2015/08/04 09:24:23 |
Okayama prospective oBservational study for the Effect by Sitagliptin on obesE type2 diabetes
OBESE
Okayama prospective oBservational study for the Effect by Sitagliptin on obesE type2 diabetes
OBESE
Japan |
type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
To examine the efficacy of sitagliptin for type 2 diabetes patients with obesity.
Efficacy
The percent and degree of change about HbA1c when treatment begins and after 3 months.
The normal rate about HbA1c and fasting blood glucose when treatment begins and after 3, 6 or 12 months.
Measure of weight, blood pressure, adverse events, pancreatic beta-cell function and lipid effects, high-sensitivity CRP, urine qualitative and microalbuminuria, 1.5AG, oxidative stress, cytokines, BNP.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Patients with type 2 diabetes (HbA1c 6.5-10% JDS) under life style intervention or treating with oral medicine
2)Age >=20 years, Male and Female
3)written informed consent
1)type 1 diabetes
2)history of severe ketosis or diabetic coma
3)Patients having severe infection, before and after operation and trauma
4)Impaired renal function (serum-creatinine: Male >=1.5mg, Female >=1.3mg)
5)history of stroke, myocardial infarction or other severe vascular complication
6)Patients treating with DPP-IV inhibitor except for sitagliptin
7)Patients treating with gurinido or insulin at initiation time
8)patients who treated with sulfonylurea (>=glimepilide 2mg/day, >= glibenclamide 1.25mg/day or >=gliclazide 40mg/day at initiation time
9)pregnancy
10)history of anaphylaxis of itagliption
11)patients who are inadequate to enter this study due to the other reasons by physician's judgments
200
1st name | |
Middle name | |
Last name | Hirofumi Makino |
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Department of Medicine and Clinical Science
2-5-1 Shikata-cho, Okayama
086-235-7235
makino@md.okayama-u.ac.jp
1st name | |
Middle name | |
Last name | Kenichi Shikata |
Okayama University Hospital
Centor for Innovative Clinical Medicine
2-5-1 Shikata-cho, Okayama
086-235-6510
okadmnet@md.okayama-u.ac.jp
Department of Medicine and Clinical Science,Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences,
Okayama Medical Foundation
Non profit foundation
Japan
NO
岡山大学病院(岡山県)、心臓病センター 榊原病院(岡山県)、岡山労災病院(岡山県)、岡山済生会総合病院(岡山県)、おさふねクリニック(岡山県)、岡山市立市民病院(岡山県)、岡山医療センター(岡山県)、岡山赤十字病院(岡山県)、津山中央病院(岡山県)、落合病院(岡山県)、浅野内科(岡山県)、宿毛診療所(岡山県)、河合内科西口クリニック(岡山県)、宮島医院(岡山県)、あけぼのクリニック(岡山県)、中国中央病院(広島県)、金光病院(岡山県)、因島総合病院(広島県)、はしもとじんクリニック(広島県)
2011 | Year | 02 | Month | 04 | Day |
Unpublished
Completed
2010 | Year | 11 | Month | 30 | Day |
2011 | Year | 02 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
Age, gender, height, weight, abdominal circumference, BMI, drinking and smoking status, diabetes duration, complications (cardiovascular disease, renal failure, liver failure, stroke, hypertension, lipid disorders), lifestyle-related diseases and drug prescription conditions (diabetes medications, antihypertensive drugs, lipid disorders treatment, antithrombotic drugs, therapeutic blood high uric acid).
Evaluation of changes (blood glucose, HbA1c, 1.5 AG), weight, blood pressure, adverse events, pancreatic beta-cell function and lipid effects, high-sensitivity CRP, urine qualitative and microalbuminuria when treatment begins and after 3, 6 or 12 months.
Oxidative stress, cytokines, BNP levels when treatment begins and after 12 months.
2011 | Year | 02 | Month | 03 | Day |
2015 | Year | 08 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005961
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