UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053234 |
|---|---|
| Receipt number | R000060752 |
| Scientific Title | Short-term weight loss and body composition changes in patients with obesity by GLP-1 and GIP/GLP-1 receptor agonists in combination with low-calorie diet. |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2023/12/30 16:07:28 |
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Basic information
Public title
Short-term weight loss and body composition changes in patients with obesity by GLP-1 and GIP/GLP-1 receptor agonists in combination with low-calorie diet.
Acronym
Short-term therapeutic effects of GLP-1 and GIP/GLP-1 receptor agonists on patients with obesity during severe energy restriction.
Scientific Title
Short-term weight loss and body composition changes in patients with obesity by GLP-1 and GIP/GLP-1 receptor agonists in combination with low-calorie diet.
Scientific Title:Acronym
Short-term therapeutic effects of GLP-1 and GIP/GLP-1 receptor agonists on patients with obesity during severe energy restriction.
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the short-term effects of GLP-1 and GIP/GLP-1 receptor agonists on weight and body composition changes in patients with obesity undergoing a low-calorie diet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage changes in body composition during inpatient treatment with low-calorie diet for thirteen days.
Key secondary outcomes
Percentage changes in body weight and body mass index, as well as systolic and diastolic blood pressure, fasting blood glucose, C-peptide, TG, HDL-C and LDL-C and subcutaneous and visceral fat area during inpatient treatment with low-calorie diet for thirteen days.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with BMI of 25 kg/m2 or higher aged 18 years or older in Japan.
(2) Patients who admitted to our hospital for weight loss between January 2019 and December 2023 and completed a 13 days low-calorie-diet therapy (LCD) provided by our hospital to replace their three daily meals.
(3) Patients who had started using oral or subcutaneous semaglutide or tirzepatide within 8 weeks prior to and 1 week after admission, or those with no history of GLP-1 receptor agonist use
Key exclusion criteria
(1) Patients who were or plan to be pregnant.
(2) Patients who were unable to cooperate with treatment due to mental illness or language barrier.
(3) Patients with a history of GLP-1 receptor agonist use other than oral and subcutaneous semaglutide and tirzepatide.
(4) Patients who failed to continue GLP-1 or GIP/GLP-1 receptor agonists during hospitalization.
(5) Patients who were unable to continue the LCD provided by our hospital.
(6) Other patients deemed inappropriate as research subjects by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
Department of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
0438-36-1071
ishibashi-cib@umin.net
Public contact
Name of contact person
| 1st name | Ryoichi |
| Middle name | |
| Last name | Ishibashi |
Organization
Kimitsu Chuo Hospital
Division name
epartment of Medicine, Division of Diabetes, Endocrinology and Metabolism
Zip code
292-8535
Address
1010 Sakurai, Kisarazu-city, Chiba
TEL
0438-36-1071
Homepage URL
ishibashi-cib@umin.net
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kimitsu Chuo Hospital
Address
1010 Sakurai, Kisarazu-city, Chiba
Tel
0438-36-1071
ishibashi-cib@umin.net
Secondary IDs
Secondary IDs
YES
Study ID_1
752
Org. issuing International ID_1
Kimitsu Chuo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 31 | 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
| 2023 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present observational study investigated the short-term effects of semaglutide and tirzepatide on weight loss and body composition in people with obesity under severe calorie restriction.
Management information
Registered date
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060752
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
