Unique ID issued by UMIN | UMIN000025036 |
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Receipt number | R000027150 |
Scientific Title | Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2018/12/03 00:24:07 |
Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity
Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity
Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity
Study to explore the effects of miglitol or sitagliptin on the incretin responses and respiratory metabolism function in type 2 diabetic patients with obesity
Japan |
Type 2 diabetes
Endocrinology and Metabolism |
Others
NO
We explore the effects of miglitol or sitagliptin on the active GLP-1 and active GIP by meal tolerance test and respiratory metabolism function (energy consumption volume) in type 2 diabetic patients with obesity who are treated with insulin therapy.
Efficacy
Exploratory
Pragmatic
Not applicable
Before and after 7 days administration of miglitol, sitagliptin
1. changes in respiratory metabolism function (energy consumption volume and respiratory quotient)
2. changes in active GIP and active GLP-1
1. Body weight and waist circumference, amount of visceral fat (Before, on discharge, 1 month after, 3 months after, 6 months after administration of miglitol, sitagliptin)
2. Blood glucose and CPR by meal tolerance test (Before and after 7 days administration of miglitol, sitagliptin)
3. Miglitol blood concentration (after 7 days administration of miglitol)
4. Blood pressure and AST, ALT, gamma-GTP, LDH, CPK, TP, Alb, BUN, Cr, TC, HDL-C, TG, apo protein, blood count, blood glucose, HbA1c, GA, CPR, catecholamine, urinary CPR, urinary BUN, urinary Cr, urinary albumin
5. Correlation between actual value of visceral fat area using abdominal computed tomographic scan and estimate value of visceral fat area using abbreviated visceral fat meter
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
2
Treatment
Medicine |
Insulin therapy + miglitol 50mg thrice a day
Insulin therapy + sitagliptin 50mg once a day
20 | years-old | <= |
85 | years-old | > |
Male and Female
1. Patients with type 2 diabetes who are admitting to Department of Diabetes, Endocrinology and Metabolism of Nippon Medical School Hospital for glycemic control
2.HbA1c >= 8.0 % on admission and insulin therapy started during hospitalization
3.Patients with obesity who BMI>=25 on admission
1. type 1 diabetes
2. with severe or asymptomatic hypoglycemic episodes
3. severe hepatic disorders
4. with viral hepatitis
5. severe renal disease
6. severe heart failure or acute coronary syndrome within the previous 6 months
7. acute or chronic pancreatitis
8. malignant tumors
9. infectious diseases, under consideration of operations or with traumatic diseases
10. severe diabetic neuropathy
11. severe diabetic retinopathy
12. with ketoacidosis or severe hyperglycemic states
13. inflammatory bowel diseases, ileus or past history of ileus
14. chronic bowel diseases with malabsorption
15. with diseases which may grow worth by bowel gas retention
16. gastrectomy
17. lactose intolerance
18. massive alcohol intake
19. pregnancy, lactation or candidates
20. patients under ongoing other clinical trials or under those within 4 months
21. severe hepatic disorders, renal disease or heart failure that seeks to influence safety
22. patients with drug hypersensitivity
23. patients who are judged as inappropriate for inclusion by physicians
40
1st name | |
Middle name | |
Last name | Hitoshi Sugihara |
Nippon Medical School Hospital, Tokyo, Japan
Department of Diabetes, Endocrinology and Metabolism
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
03-3822-2131
hitoshi@nms.ac.jp
1st name | |
Middle name | |
Last name | Kyoko Inagaki |
Nippon Medical School Hospital, Tokyo, Japan
Department of Diabetes, Endocrinology and Metabolism
1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan
03-3822-2131
s3068@nms.ac.jp
Nippon Medical School Hospital, Tokyo, Japan
SANWA KAGAKU KENKYUSHO CO.,LTD.
Profit organization
NO
2016 | Year | 12 | Month | 01 | Day |
Unpublished
Terminated
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 09 | Month | 01 | Day |
2016 | Year | 11 | Month | 29 | Day |
2018 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027150
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