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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044385
Receipt No. 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 2021/05/31

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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
Email 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
Email t-onoue@med.nagoya-u.ac.jp

Sponsor
Institute Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine
Institute
Department

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
Email 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
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
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
2024 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
2021 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050700

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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