Unique ID issued by UMIN | UMIN000029999 |
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Receipt number | R000034258 |
Scientific Title | Controlled study of the effects on glucose metabolism and gut microbiome by the treatment of sleep disorders |
Date of disclosure of the study information | 2017/12/01 |
Last modified on | 2022/05/23 19:22:27 |
Controlled study of the effects on glucose metabolism and gut microbiome by the treatment of sleep disorders
correlation of sleep, glucose metabolism and gut microbiome
Controlled study of the effects on glucose metabolism and gut microbiome by the treatment of sleep disorders
correlation of sleep, glucose metabolism and gut microbiome
Japan |
diabetes mellitus, sleep disorders
Medicine in general |
Others
NO
To clarify the possible correlation among sleep rhythms disorders, gut microbiome, and glucose metabolism
Efficacy
The change of gut bacterial composition, increase or decrease of each bacterial phylum
Interventional
Parallel
Non-randomized
Open -no one is blinded
Placebo
2
Treatment
Medicine |
To analyse and compare gut microbime and glucose metabolism before and after 3months treatment by melatonin-receptor agonist(ramelteon)
To analyse and compare gut microbime and glucose metabolism before and after 3months treatment by orexin receptor antagonist(suvorexant)
20 | years-old | <= |
75 | years-old | > |
Male and Female
patients with type 2 diabetes and sleep disorders
HbA1c<6.5% or >=10%
severe liver dysfunction
severe renal dysfunction(eGFR<30)
previous cerebral infarction or myocardial infarction
pregnant or breast-feeding
hypersensitive to applicable drug
judged as inappropriate by attending physician
50
1st name | Masahiro |
Middle name | |
Last name | Nishi |
Wakayama Medical University
Division of Clinical Nutrition and Metabolism
641-8509
811-1 Kimiidera, Wakayama-City, Wakayama prefecture
073-441-0625
mnishi@wakayama-med.ac.jp
1st name | Shuhei |
Middle name | |
Last name | Morita |
Wakayama Medical University
The First Department of Medicine
641-8509
811-1 Kimiidera, Wakayama-City, Wakayama prefecture
073-441-0625
shuhei0528@gmail.com
Wakayama Medical University
Wakayama Medical University
Other
Research Ethics Committee of Wakayama Medical University
811-1 Kimiidera, Wakayama-City, Wakayama prefecture
073-447-2300
wa-rinri@wakayama-med.ac.jp
NO
2017 | Year | 12 | Month | 01 | Day |
Nothing
Unpublished
Nothing
0
The Study was stopped.
2022 | Year | 05 | Month | 20 | Day |
The Study was stopped.
The Study was stopped.
Nothing
The Study was stopped.
Terminated
2017 | Year | 11 | Month | 13 | Day |
2017 | Year | 11 | Month | 13 | Day |
2017 | Year | 12 | Month | 01 | Day |
2021 | Year | 02 | Month | 11 | Day |
2021 | Year | 02 | Month | 11 | Day |
2021 | Year | 02 | Month | 11 | Day |
2021 | Year | 02 | Month | 11 | Day |
Because of retirement of collaborative researchers, it would be very difficult to achieve this study. Therefore, this study was stopped.
2017 | Year | 11 | Month | 16 | Day |
2022 | Year | 05 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034258
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