UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055418 |
|---|---|
| Receipt number | R000061141 |
| Scientific Title | Follow up Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders |
| Date of disclosure of the study information | 2024/09/04 |
| Last modified on | 2025/03/13 09:45:16 |
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Basic information
Public title
Follow up Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders
Acronym
SLIM-TARGET Follow up Study
Scientific Title
Follow up Study of weight Loss Intervention to find effective strategy for obesity Management and the TARGET of weight loss amount for reducing health disorders
Scientific Title:Acronym
SLIM-TARGET Follow up Study
Region
| Japan |
Condition
Condition
obesity, health disorders including type 2 diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to be the first long-term observation in Japan of the improvement effects of a weight loss intervention for obese patients on multiple health disorders, including type 2 diabetes, and to generate new evidence to improve the quality of actual medical care for obesity and type 2 diabetes. To this end, the SLIM-TARGET study, a randomised controlled intervention study currently underway (to be completed in FY2022), will be transferred to a follow-up study and made into a registry to maximise the use of this research resource and generate real-world evidence for the treatment of obesity and type 2 diabetes in the post-corona.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of patients with weight loss and improvement in two or more comorbid health problems (quantifiable obesity-related diseases) at 60 months of intervention.
Key secondary outcomes
Secondary efficacy endpoints
Proportion of patients meeting at least two of the above (primary endpoints) at 36 and 48 months.
Percentage of patients who lost weight at 36 months.
Percentage of patients with a reduction in the treatment for a health problem at 48 months.
Percentage of patients with a reduction in the medicinal treatment for a health problem at 60 months.
Percentage of cases meeting one of the above-mentioned improvements in health problems at 36 months
Percentage of cases meeting one of the above-mentioned improvements in health problems at 48 months
Percentage of cases meeting one of the above-mentioned improvements in health disability at 60 months.
Proportion of cases with zero disability
Percentage change in body weight
Reduction in visceral fat mass
Percentage reduction in HbA1c
Percentage change in serum lipids
Percentage decrease in AST
Rate of decrease in ALT
Rate of decrease in gamma-GTP
Percentage decrease in systolic and diastolic blood pressure
Percentage decrease in Epworth Sleepiness Scale score
Percentage change in willingness to treat, joint pain and dysmenorrhoea scores in the study subjects using the questionnaire
Drop-out rate of study subjects in the standard and intensified treatment groups
Secondary safety endpoints
Frequency of adverse events.
Incidence frequency of sudden death, cardiovascular events, stroke, malignancy, psychiatric disorders, musculoskeletal disorders, etc.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be included.
1) Patients who have participated in the SLIM-TARGET study.
2) Patients who have given a full explanation of their participation in this study (FU study), and who have given their free and voluntary written consent based on a full understanding of the study.
Key exclusion criteria
The present study (FU study) has no specific exclusion criteria.
Target sample size
294
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Yokote |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Endocrinology, Hematology and Gerontology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan.
TEL
043-222-7171
willo_the_wisp_mayumi@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Shoji |
Organization
Chiba University Graduate School of Medicin
Division name
Department of Endocrinology, Hematology and Gerontology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan
TEL
043-222-7171
Homepage URL
adaa4124@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate Schoo
Institute
Department
Personal name
Funding Source
Organization
Suzuki Manpei foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Observational Research Ethics Review Committee
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan.
Tel
043-222-7171
hsp-kansaturinri@chiba-u.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
| 2024 | Year | 09 | Month | 04 | 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
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Aims and significance of the study :.
The aim of the study is to generate new evidence to improve the quality of actual medical care for obesity and type 2 diabetes by observing, for the first time in Japan, long-term improvement effects of weight loss interventions on multiple health disorders, including type 2 diabetes, in obese patients.
Study design :Multi-institutional, observational study
selection criteria:Patients who meet all of the following criteria will be included.
1) Patients who participated in the SLIM-TARGET study.
2) Patients who have given a full explanation of their participation in this study and have given their free written consent with full understanding.
Exclusion criteria There are no specific exclusion criteria for this study.
Endpoints Primary endpoint
Proportion of patients with weight loss and improvement in two or more comorbid health problems (quantifiable obesity-related diseases) at 60 months of intervention.
Secondary endpoints:
Secondary efficacy endpoints
Proportion of patients meeting at least two of the above (primary endpoints) at 36 and 48 months.
Proportion of patients who achieved a reduction in the dose of treatment for a health problem at 36 months.
Percentage of patients with a reduction in the treatment for a health problem at 48 months.
Percentage of patients with a reduction in the medicinal treatment for a health problem at 60 months.
Percentage of cases meeting one of the above-mentioned improvements in health problems at 36 months
Percentage of cases meeting one of the above-mentioned improvements in health problems at 48 months
Percentage of cases meeting one of the above-mentioned improvements in health disability at 60 months.
Proportion of cases with zero disability
Percentage change in body weight
Reduction in visceral fat mass (%)
Percentage reduction in HbA1c and etc.
Management information
Registered date
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061141
