UMIN-CTR Clinical Trial

Basic information
Public title	Effect of GLP1 receptor agonist on gastric emptying rate in type 2 DM
Acronym	Effect of GLP1 receptor agonist on gastric emptying rate in type 2 DM
Scientific Title	Effect of GLP1 receptor agonist on gastric emptying rate in type 2 DM
Scientific Title:Acronym	Effect of GLP1 receptor agonist on gastric emptying rate in type 2 DM
Region	Japan

Condition
Condition	type2 DM
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the differences in the effects of GLP-1 receptor agonists weight loss and gastric emptying rate.
Basic objectives2	Others
Basic objectives -Others	GLP-1 receptor agonists are known to have a weight loss effect. And the effects of various drugs against weight loss are different, but the mecahnism is not fully understood. This study was designed considering that the different effects on gastric emptying may be related to the weight loss effect. Various GLP-1 receptor agonists are administered, and after 12 weeks, changes in body weight and gastric emptying rate are examined, and their relationships are investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in glucose, insulin, and gastric emptying rate after administration of GLP-1RA for 12 weeks
Key secondary outcomes	Changes in glucose, insulin, and gastric emptying rate after administration of GLP-1RA for 12 weeks

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	40 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Japanese individuals with type 2 diabetes, untreated or receiving biguanides or sulfonylureas. Inclusion criteria were as follows: Age 40-75 years, HbA1c 12.0% or less, and BMI 40 kg/m2 or less.
Key exclusion criteria	Subjects with type 1 diabetes, severe diabetic autonomic neuropathy, gastrointestinal tract disease including gastroparesis, history of gastrointestinal operation, cardiac disease, pulmonary disease, pancreatic disease, thyroid disease, liver disease, renal disease, alcohol or drug abuse, anti-diabetes drugs other than biguanides or sulfonylureas, diabetogenic medication, malignancy, or pregnancy.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Kuwata Middle name Last name Hitoshi
Organization	Kansai Electric Power Medical Research Institute
Division name	Division of Translational Diabetology
Zip code	553-0003
Address	2-1-7 Fukushima-ku, Osaka 553-0003, Japan
TEL	+81-6-6458-5821
Email	kuwata-kob@umin.ac.jp

Public contact
Name of contact person	1st name kuwata Middle name Last name Hitoshi
Organization	Kansai Electric Power Medical Research Institute
Division name	Division of Translational Diabetology
Zip code	553-0003
Address	2-1-7 Fukushima-ku, Osaka 553-0003, Japan
TEL	06-6458-5821
Homepage URL
Email	kuwata-kob@umin.ac.jp

Sponsor
Institute	Kansai Electric Power medical Intitute
Institute
Department

Funding Source
Organization	self funding
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	Kansai Electric Power Hospital
Address	2-1-7 Fukushima-ku, Osaka 553-0003, Japan
Tel	+81-6-6458-5821
Email	kuwata-kob@umin.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	25-34
Org. issuing International ID_1	Kansai Electric Power Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 20 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	15
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	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 01 Day
Date of IRB	2013 Year 08 Month 28 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Participants were subjected to meal tolerance tests in the morning after overnight fast after 0wks, 2wks and 12wks GLP-1RA adminsitration. Bodyweight, glucose, lipid profile and hormons, including total GIP, Glucagon and Insulin, were measured. Gastric emptying rate was determined by mathematical modeling based on changes of 13CO2/12CO2 ratio in breath samples measured by an infrared spectral analyzer .

Management information
Registered date	2020 Year 12 Month 20 Day
Last modified on	2020 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048612