Unique ID issued by UMIN | UMIN000013356 |
---|---|
Receipt number | R000015584 |
Scientific Title | Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial |
Date of disclosure of the study information | 2014/03/06 |
Last modified on | 2017/02/17 08:37:55 |
Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial
Sitagliptin Effect on fatty liver and Lipid Metabolism study
Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial
Sitagliptin Effect on fatty liver and Lipid Metabolism study
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To compare effects of DPP4 inhibitor, sitagliptin and Sulfonylurea on intrahepatic adipose mass and lipid metabolism and fatty mass in patients with type 2 diabetes accompanied by fatty liver .
Safety,Efficacy
amount of Intrahepatic adipose mass and visceral fat(MRI,DEXA)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
sitagliptin administration group
Glimepiride administration group
20 | years-old | <= |
85 | years-old | > |
Male and Female
1)Inadequately controlled type 2 diabetic patients who are not taking antidiabetic agent other than metformin for more than 2 month. Patients whose HbA1c ranges from 6.9% to 9.4%.
2)Patients who had Fatty liver, or Patients whose IHL(intrahepatic lipid content)is more than 10% on 1H-MRS, or Patients who had metabolic syndrome fulfilled the diagnostic criteria, or Patients whose BMI is more than 25.
3)Patients who have been received diabetes treatment for more than 6 months.
4)over 20 years age
5)Out patient
6)Gender is not restricted.
7)Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start.
1)Patients who had diabetic ketosis, or diabetic pre-coma and coma within 6 months of the study entry.
2)Patients with severe infections, before or after operation, or with serious trauma.
3)Patients with pregnancy, possibility of pregnancy or having a breast feeding.
4)Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl)
5)Patients who received insulin therapy.
6)Patients who administered antihyperlipidemic agent other than Metformin for observation period.
7)Patients who had a history of hypersensitive reaction to DPP-4 inhibitor.
8)Patients whom the attending doctor estimated to be ineligible according to the medical rationale.
60
1st name | |
Middle name | |
Last name | Yasushi Tanaka |
St.Marianna University School of Medicine
Division of Endocrinology and Metabolism
2-16-1
044-977-8111
h.k.kato@marianna-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroyuki Kato |
St.Marianna University School of Medicine Hospital
Division of Endocrinology and Metabolism
2-16-1 Sugou, Miyamae-ku Kawasaki-city Kanagawa-ken
044-977-8111
y2tanaka@marianna-u.ac.jp
St.Marianna University School of Medicine
Kawasaki Diabetes Mellitus Square
Other
Japan
NO
聖マリアンナ医科大学病院(神奈川県)
2014 | Year | 03 | Month | 06 | Day |
Published
Completed
2011 | Year | 04 | Month | 01 | Day |
2014 | Year | 12 | Month | 31 | Day |
2014 | Year | 03 | Month | 06 | Day |
2017 | Year | 02 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015584