UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042797 |
|---|---|
| Receipt number | R000048612 |
| Scientific Title | Effect of GLP1 receptor agonist on gastric emptying rate in type 2 DM |
| Date of disclosure of the study information | 2020/12/20 |
| Last modified on | 2020/12/20 17:06:52 |
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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
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
kuwata-kob@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power medical Intitute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048612
