UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059672 |
|---|---|
| Receipt number | R000066512 |
| Scientific Title | a study on patient profiles of obesity patients with semaglutide |
| Date of disclosure of the study information | 2025/11/06 |
| Last modified on | 2025/11/06 22:03:42 |
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Basic information
Public title
a study on patient profiles of obesity patients with semaglutide
Acronym
a study on patient profiles of obesity patients with semaglutide
Scientific Title
a study on patient profiles of obesity patients with semaglutide
Scientific Title:Acronym
a study on patient profiles of obesity patients with semaglutide
Region
| Japan |
Condition
Condition
obesity patiennts
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the patient background in which semaglutide administration is effective for patients with obesity, as well as to examine the involvement of dietitians in the care of patients with obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Food Frequency Questionnaire (FFQ) and eating behavior assessments at 6 months before starting semaglutide, at the time of initiation, and at 6, 12, and 18 months after starting
Key secondary outcomes
Change in body mass index
Change in body weight
Change in waist circumference
Change in blood pressure
Change in pulse rate
Change in HbA1c
Change in blood glucose level
Change in LDL-Cholesterol
Change in HDL-Cholesterol
Change in triglycerides
Change in Aspartate Aminotransferase
Change in Alanine Aminotransferase
Change in Gamma-Glutamyl Transferase
Change in body fat mass
Change in muscle mass
Change in skeletal muscle mass
Change in basal metabolic rate
Change in average energy expenditure
Change in average step count
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Semaglutide injection
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Obesity
2. Patients scheduled for semaglutide administration
3. Indications for semaglutide: Obesity, provided that the patient has hypertension, dyslipidemia, and/or type 2 diabetes, and dietary and exercise therapy alone are not enough to control body weight and metabolic disorders, limited to cases meeting the following criteria:
> BMI is 27 kg/m2 or higher and has two or more obesity-related health issues
> BMI is 35 kg/m2 or higher
Key exclusion criteria
1.Individuals who do not consent to participate in the study
2.Those whom the principal investigator or co-investigator determines are not suitable to participate in this clinical research
3.Women who are pregnant or may be pregnant
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Maeda |
Organization
HEC Science Clinic
Division name
Department of Diabetes
Zip code
2350045
Address
4-1-4-102 Youkoudai Isogoku Yokohama Kanagawa
TEL
0458310031
hec@asahi-net.email.ne.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Maeda |
Organization
HEC Science Clinic
Division name
Department of Diabetes
Zip code
2350045
Address
4-1-4-102 Youkoudai Isogoku Yokohama Kanagawa
TEL
0458310031
Homepage URL
hec@asahi-net.email.ne.jp
Sponsor or person
Institute
HEC Science Clinic
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
HEC Science Clinic
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HEC Science Clinic Ethics Committee
Address
4-1-4-102 Youkoudai Isogoku Yokohama Kanagawa
Tel
0458310031
hec@asahi-net.email.ne.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
HECサイエンスクリニック(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066512
