UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014223 |
|---|---|
| Receipt number | R000016569 |
| Scientific Title | The clinical study to explore the effects of sodium-dependent glucose co-transporter 2 inhibitors on responses of orexigenic hormone 'ghrelin' in patients with type 2 diabetes |
| Date of disclosure of the study information | 2014/06/16 |
| Last modified on | 2018/01/30 01:09:02 |
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Basic information
Public title
The clinical study to explore the effects of sodium-dependent glucose co-transporter 2 inhibitors on responses of orexigenic hormone 'ghrelin' in patients with type 2 diabetes
Acronym
Effects of SGLT2 inhibitors on ghrelin secretion in patients with type 2 diabetes
Scientific Title
The clinical study to explore the effects of sodium-dependent glucose co-transporter 2 inhibitors on responses of orexigenic hormone 'ghrelin' in patients with type 2 diabetes
Scientific Title:Acronym
Effects of SGLT2 inhibitors on ghrelin secretion in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors on plasma ghrelin level in patients with type 2 diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
changes in plasma ghrelin level before and after 2-week administration of SGLT2 inhibitors
Key secondary outcomes
changes in glycated albumin,glucagon, leptin, growth hormone, insulin-like growth factor-1, antidiuretic hormone, LDL-cholesterol, HDL-cholesterol,C-peptide immunoreactivity, sodium, body composition, body weight, blood pressure, frequency scale for symptoms of gastroesophageal reflux disease and visual analogue sacle for appetite before and after 2-week administration of SGLT2 inhibitors
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sodium-dependent glucose co-transporter 2 inhibitors(SGLT2 inhibitors)
Interventions/Control_2
insulin or its analogues and oral hypoglycemic agents
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)patients with type 2 diabetes mellitus
2)ability to provide written informed consent for this study
3)inpatients
4)HbA1c>=7.0%
3)patients without change of treatment for the past 28 days
Key exclusion criteria
1)Body Mass Index <22
2)an excessive alcohol drunker
3)patients who were added same drugs during the course of the trial
4)patients with severe ketosis, diabetic coma or precoma
5)patients with hepatic dysfunction(child-pugh B or worse) or severe renal dysfunction(eGFR<50)
6)patients with severe infection, perioperative period or severe injury
7)patients with allergy for SGLT2 inhibitors
8)patients with a history of gastrointestinal tract surgery
9)pregnant women or women that may have become pregnant
10)patients determined to be inappropriate by physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akamizu Takashi |
Organization
Wakayama medical university
Division name
The first department of medicine
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-461-0625
akamizu@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Ota |
Organization
Wakayama medical university
Division name
The first department of medicine
Zip code
Address
811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL
073-461-0625
Homepage URL
tota@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university, the first department of medicine
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university, the first department of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和歌山県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 10 | Day |
Last modified on
| 2018 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016569
