UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044385 |
|---|---|
| Receipt number | R000050700 |
| Scientific Title | A study on the safety and effectiveness of "a weight loss program by setting energy intake considering changes in basal metabolic rate" |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2024/12/06 16:27:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study on the safety and effectiveness of "a weight loss program by setting energy intake considering changes in basal metabolic rate"
Acronym
A weight loss program by setting energy intake considering changes in basal metabolic rate
Scientific Title
A study on the safety and effectiveness of "a weight loss program by setting energy intake considering changes in basal metabolic rate"
Scientific Title:Acronym
A weight loss program by setting energy intake considering changes in basal metabolic rate
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a weight loss program that sets an appropriate calorie intake based on resting metabolic rate and to examine the efficacy and safety of the program.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in body weight
Key secondary outcomes
Changes in resting metabolic rate, body composition, and BMI
Changes in HbA1c level, lipids, and blood pressure
Changes in various blood and urine test items
Changes in calorie intake
Changes in physical activity
Change in hunger scale
3% or 5% weight loss achievement rate
Adverse events (safety)
An exploratory study in patients with high weight loss
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Providing an appropriate diet based on resting metabolic rate and physical activity (24 weeks)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with obesity
2) Patients who are aged >=18 years and <65 years
3) Patients who have not participated in other weight loss programs in the last 8 weeks
4) Patients who provide their consent in a written form by themselves
Key exclusion criteria
The exclusion criteria are as follows:
1) Secondary obesity (symptomatic obesity)
2) Patients who had a history of highly invasive surgery, severe trauma, severe infection disease, malignant tumor, or hyperthyroidism within six months
3) Patients with severe impairment in cardiorespiratory, renal or liver function to whom exercise therapy is not applicable (includes patients estimated glomerular filtration rate < 30 mL/min/1.73 m2)
4) Patients with severe musculoskeletal impairment to whom exercise therapy is not applicable
5) Patients who are pregnant, suspected of being pregnant, within 28 days of parturition, or breastfeeding
6) Patients who are judged by their physicians to be unsuitable for participation in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Arima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2142
arima105@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Onoue |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Endocrinology and Diabetes
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2142
Homepage URL
t-onoue@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine
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
ethical committee of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-Cho, Showa-ku, Nagoya, Aichi
Tel
052-744-2479
ethics@med.nagoya-u.ac.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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 01 | 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
20
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
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 31 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050700
