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 2023/06/02 09:10:24

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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 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

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

Enrolling by invitation

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

2023 Year 06 Month 02 Day



Link to view the page

Value
https://center6.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