UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015699 |
|---|---|
| Receipt number | R000018249 |
| Scientific Title | Effects of exenatide on postprandial vascular endothelial function in type 2 diabetes mellitus |
| Date of disclosure of the study information | 2014/11/15 |
| Last modified on | 2014/11/15 18:20:17 |
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Basic information
Public title
Effects of exenatide on postprandial vascular endothelial function in type 2 diabetes mellitus
Acronym
Effects of exenatide on postprandial vascular endothelial function in type 2 diabetes mellitus
Scientific Title
Effects of exenatide on postprandial vascular endothelial function in type 2 diabetes mellitus
Scientific Title:Acronym
Effects of exenatide on postprandial vascular endothelial function in type 2 diabetes mellitus
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines whether the GLP-1 analog exenatide would inhibit postprandial vascular endothelial dysfunction in patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the difference between changes in postprandial vascular endothelial function without eventide administration compared with single-dose exenatide administration.
Key secondary outcomes
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
Patients with type 2 diabetes mellitus undergo a meal tolerance test to examine changes in postprandial endothelial function and changes in glucose and lipid metabolism without exenatide administration (day 1) and after single-dose exenatide administration (day 2). On day 1, no exenatide is administered, whereas a subcutaneous injection of exenatide is administered 15 min before meal loading on day 2.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) age 20 to less than 80; 2) no change in oral antihyperglycemic drug therapy, lipid metabolism-improving drug therapy, or antihypertensive drug therapy during the 12 weeks preceding enrollment; and 3) ongoing treatment by diet regimen alone or by therapy with sulfonylurea, sulfonylurea plus biguanide, or sulfonylurea plus thiazolidine derivatives.
Key exclusion criteria
1) receiving insulin therapy; 2) having diabetic ketoacidosis, nonketotic hyperosmolar coma, infection, or acute coronary syndrome; 3) being pregnant or possibly pregnant; 4) having a history of stroke or ischemic heart disease occurring within the preceding 6 months; 5) having a history of pancreatitis; and 6) having arrhythmia.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Okada |
Organization
School of Medicine, University of Occupational and Environmental Health
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushyu-shi 807-8555, Japan.
TEL
093-603-1611
y-okada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichi Torimoto |
Organization
School of Medicine, University of Occupational and Environmental Health
Division name
First Department of Internal Medicine
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushyu-shi 807-8555, Japan.
TEL
090-603-1611
Homepage URL
torimoto@med.uoeh-u.ac.jp
Sponsor or person
Institute
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
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 | 11 | Month | 15 | 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
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
| 2014 | Year | 11 | Month | 15 | Day |
Last modified on
| 2014 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018249
