UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of GLP-1 receptor agonist on digestive tract movement evaluation using capsule endoscopy
Title of the study (Brief title)	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	Nakatai Yuki
Organization	Dokkyo Medical University Nikko Medical Center
Division name	Diabetes and Endcrinology
Address	Tochigiken Nikkoshi Takatoku632
TEL	0288-76-1515
Email	yu-naka@dokkyomed.ac.jp

Public contact
Name of contact person	Nakatani Yuki
Organization	Dokkyo Medical University Nikko Medical Center
Division name	Diabetes and Endcrinology
Address	Tochigiken Nikkoshi Takatoku632
TEL	0288-76-1515
Homepage URL
Email	yu-naka@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University Nikko Medical Center
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025017