UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005666 |
|---|---|
| Receipt number | R000006677 |
| Scientific Title | Effect of sitagliptin on ectopic fat accumulation and glucose metabolism. |
| Date of disclosure of the study information | 2011/05/30 |
| Last modified on | 2017/12/02 10:05:03 |
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Basic information
Public title
Effect of sitagliptin on ectopic fat accumulation and glucose metabolism.
Acronym
Effect of sitagliptin on ectopic fat accumulation and glucose metabolism.
Scientific Title
Effect of sitagliptin on ectopic fat accumulation and glucose metabolism.
Scientific Title:Acronym
Effect of sitagliptin on ectopic fat accumulation and glucose metabolism.
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of sitagliptin on ectopic fat accumulation and glucose metabolism in type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intrahepatic lipid, intramyocellular lipid
Glucose metabolism after oral glucose load
HbA1c
Key secondary outcomes
Liver function test
Body weight
Body fat
Visceral fat, subcutaneous fat volume
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
50 - 100mg of sitagliptine for 12 weeks
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The type 2 diabetic patients whose HbA1c are between 6.5 % and 8.0%.
2. The patients with fatty liver.
3. The patients who have already started diet and exercise therapy for more than 6 months.
4. The patients who are more than 20 year-old.
5. Male or Female
6. The patients who are able to read and understand the written informed consent.
Key exclusion criteria
1) Type 1 diabetes
2) Heavy alcohol drinker
3) Patients who have serious liver disease
4) Patients who have serious kidney disease
5) Patients who have serious heart disease ( patients who have apparent heartfailure or myocardial infarction within 3 months)
6) Patients who have serious pancreatic disease
7) Patients with cancer
8) Patients who have viral infection (HBV,HCV)
9) Patients with serious diabetic complications including progressed neutopathy and proliferative retinopathy
10) Patietns with serious infection, inflammation, or injuary. pre- or post- operative state
11) Patients who have inflammatory bowel disease, ulcer in bowel, ileus and high risk for ileus
12) Patients who are pregnant, hope to be pregnant, or are in lactation period
13) Patients who take pioglitazone
14) Patients who are not applicable to this study judged by the medical doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Tamura |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolisma and Endocrinology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
Address
TEL
03-5802-1579
Homepage URL
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research Conference on Japanese Diabetes Mellitus
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | 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
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2017 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006677
