UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015867 |
|---|---|
| Receipt number | R000018463 |
| Scientific Title | Effect of GLP-1 receptor agonist in combination with insulin on abdominal fat in patients with type 2 diabetes trial |
| Date of disclosure of the study information | 2014/12/15 |
| Last modified on | 2016/12/08 07:56:04 |
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Basic information
Public title
Effect of GLP-1 receptor agonist in combination with insulin on abdominal fat in patients with type 2 diabetes trial
Acronym
GLP-1 receptor agonist and abodominal fat in diabetes
Scientific Title
Effect of GLP-1 receptor agonist in combination with insulin on abdominal fat in patients with type 2 diabetes trial
Scientific Title:Acronym
GLP-1 receptor agonist and abodominal fat in diabetes
Region
| Japan |
Condition
Condition
Patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of liraglutide on the abdominal fat accumulation and hepatic fat deposit in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in visceral fat area 24 after administration of liraglutide
Key secondary outcomes
The change in liver attenuation index 24 after administration of liraglutide
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
Liraglutide 0.9 mg added to insulin treatment
Interventions/Control_2
insulin alone
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
Type 2 diabetic patients treated with insulin whose HbA1c levels are between 7 and 10% and BMI levels are> or = 25 kg/m2
Key exclusion criteria
Type 1 diabetes
Patients with allergy to incretin mimetics
Patients with interstitial pneumonia
Patints with liver chirrosis or renal failure
Patients who had experienced acute coronary syndrome or stroke or acute pancreatitis within 3 months prior to enrollment
Patients with malignant neoplasms
Patients who are alread treated with DPP4 inhibitors and/or GLP-1 receptor agonists.
Patients whose dosage of insulin has been changed by > 20 % within 3 months prior to enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Departmet of Molecular Endocrinology and Metabolism
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
bouchi.mem@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Departmet of Molecular Endocrinology and Metabolism
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
bouchi.mem@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27916783
Number of participants that the trial has enrolled
Results
Liraglutide treatment significantly reduced visceral fat area (VFA) at 24 weeks; whereas, subcutaneous fat are (SFA) was unchanged. albuminuria, liver attenuation index, and CRP levels were significantly reduced by liraglutide at 24 weeks and there was no difference in skeletal muscle index between the two groups.
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
| 2014 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 15 | 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 | 12 | Month | 06 | Day |
Last modified on
| 2016 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018463
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
