UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057618 |
|---|---|
| Receipt number | R000065771 |
| Scientific Title | Investigation of the effects of anti-obesity drugs on the metabolic system |
| Date of disclosure of the study information | 2025/04/15 |
| Last modified on | 2025/04/15 14:42:43 |
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Basic information
Public title
Investigation of the effects of anti-obesity drugs on the metabolic system
Acronym
Investigation of the effects of anti-obesity drugs on the metabolic system
Scientific Title
Investigation of the effects of anti-obesity drugs on the metabolic system
Scientific Title:Acronym
Investigation of the effects of anti-obesity drugs on the metabolic system
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effects of semaglutide or tirzepatide administration on the metabolic system in obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight and metabolic parameters
Key secondary outcomes
Adverse Events
Survey Form
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A person whose BMI is one of the following: BMI 27kg/m2 or higher and has two or more obesity-related health problems , BMI 35kg/m2 or higher
A person who has type 2 diabetes, hypertension, or dyslipidemia and is on drug therapy
A person who has been receiving nutritional guidance at least once every two months for six months or Those who have been receiving nutritional guidance at least once every 2 months for at least 6 months.
Persons who are undergoing exercise therapy.
Key exclusion criteria
History of acute diabetic complications (e.g., diabetic ketoacidosis) or noted
History of severe hypoglycemia (requiring assistance from others or transport to hospital)
Severe infectious disease
Alcoholism
Severe mental illness
History of diagnosis of malignancy
Person deemed inappropriate by attending physician to participate in research
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | satoshi |
| Middle name | |
| Last name | ida |
Organization
Ise Red Cross Hospital
Division name
Diabetes and Metabolism
Zip code
516-8512
Address
1-471-2 Funae, Ise City, Mie Prefecture
TEL
0596282171
bboy98762006@yahoo.co.jp
Public contact
Name of contact person
| 1st name | satoshi |
| Middle name | |
| Last name | ida |
Organization
Ise Red Cross Hospital
Division name
Diabetes and Metabolism
Zip code
516-8512
Address
1-471-2 Funae, Ise City, Mie Prefecture
TEL
0596282171
Homepage URL
bboy98762006@yahoo.co.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Institute
Department
Personal name
satoshi ida
Funding Source
Organization
Ise Red Cross Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ise Red Cross Hospital Ethics Review Committee
Address
1-471-2 Funae, Ise-shi, Mie, Japan
Tel
0596282171
jimubu@ise.jrc.or.jp
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
| 2025 | Year | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special note
Management information
Registered date
| 2025 | Year | 04 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065771
