UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021686 |
|---|---|
| Receipt number | R000025017 |
| Scientific Title | Effect of GLP-1 receptor agonist on digestive tract movement evaluation using capsule endoscopy |
| Date of disclosure of the study information | 2016/03/30 |
| Last modified on | 2018/11/17 17:26:35 |
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Basic information
Public title
Effect of GLP-1 receptor agonist on digestive tract movement evaluation using capsule endoscopy
Acronym
Effect of GLP-1 receptor agonist on digestive tract movement evaluation
Scientific Title
Effect of GLP-1 receptor agonist on digestive tract movement evaluation using capsule endoscopy
Scientific Title:Acronym
Effect of GLP-1 receptor agonist on digestive tract movement evaluation
Region
| Japan |
Condition
Condition
Type 2 DM
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
GLP-1 receptor agonists (GLP-1 RAs) exhibit physiological actions, such as incretin actions, gastric emptying-delaying effects, and appetite-reducing actions through the suppression of digestive tract movement. In humans, the gastric emptying-delaying or digestive tract movement-reducing actions have been quantitatively assessed using the acetaminophen method. However, it is impossible to evaluate the effects on the movement of each digestive tract using this method. In this study, we quantitatively evaluated the actions of a GLP-1 RA on digestive tract movement by examining the gastrointestinal transit time using capsule endoscopy before and after administration.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capsule endoscopy was performed once administration of the liraglutide at 0.9 mg for 1 week or more.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
liraglutide group, administration of the drug by titration at 0.3 mg at 7:30 a.m. (before breakfast) was started, and the dose was increased by 0.3 mg every week until it reached 0.9 mg
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with type 2 DM doing a hospitalizing for diabetes
Patients with no history of treatment to GLP-1 or DDP-4 inhibitor
Key exclusion criteria
Type 1 DM
Severe diabetic neuropathy
history of pancreatitis
Pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakatai Yuki |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Diabetes and Endcrinology
Zip code
Address
Tochigiken Nikkoshi Takatoku632
TEL
0288-76-1515
yu-naka@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nakatani Yuki |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Diabetes and Endcrinology
Zip code
Address
Tochigiken Nikkoshi Takatoku632
TEL
0288-76-1515
Homepage URL
yu-naka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
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
獨協医科大学日光医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | 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
| 2015 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 13 | 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
| 2016 | Year | 03 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025017
