UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053018 |
|---|---|
| Receipt number | R000060478 |
| Scientific Title | Cognitive Behavioral Therapy as an Intervention to Prevent Weight Rebound post Semaglutide Discontinuation |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/06 16:00:52 |
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Basic information
Public title
Cognitive Behavioral Therapy as an Intervention to Prevent Weight Rebound post Semaglutide Discontinuation
Acronym
REBOUND-STOP
Scientific Title
Cognitive Behavioral Therapy as an Intervention to Prevent Weight Rebound post Semaglutide Discontinuation
Scientific Title:Acronym
REBOUND-STOP
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the role of cognitive behavioral therapy as an intervention to prevent weight rebound after discontinuation of semaglutide in obese patients with hypertension or dyslipidemia.
Specifically, we will examine the effectiveness of applying cognitive behavioral therapy in parallel with semaglutide treatment and its impact on preventing weight rebound in this population.
To achieve this objective, we will conduct a randomized controlled study of 40 obese patients with a BMI of 27 kg/m or higher and comorbid hypertension or dyslipidemia. One group received subcutaneous injections of semaglutide (maximum dose 2.4 mg/week), and the other group received subcutaneous injections of semaglutide (maximum dose 2.4 mg/week) and cognitive behavioral therapy once every two weeks.
The primary endpoint of this study was the rate of change in body weight from the day semaglutide was discontinued until 24 weeks after discontinuation.
Secondary endpoints include changes in waist circumference, blood pressure, lipid profile, and other metabolic parameters. We will also assess participants' adherence to cognitive behavioral therapy and assess the impact on weight maintenance post-treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight change rate from discontinuation of semaglutide to 24 weeks after discontinuation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention details: Subjects were divided into two groups. Group 1 received no intervention, and in addition to nutritional guidance (once a month) and exercise guidance (once a month) as a regular obesity outpatient clinic, they also received semaglutide administration (once a month). times/week). Semaglutide is treated by the treating physician using the dosage and dosage commonly used in clinical practice. (The specific administration method is to start with 0.25 mg/week and increase the dose every 4 weeks as 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg. If you experience nausea or vomiting symptoms while increasing the dose, Semaglutide should be continued after one step of weight loss. Semaglutide should be administered only if the patient and doctor have performed sufficient IC, and if weight loss is not observed for several weeks, nausea symptoms are severe, or the cost burden is difficult, etc. ) If semaglutide is discontinued after 24 weeks of administration, various tests such as weight measurement and body fat measurement will be conducted 24 weeks after discontinuation. If a patient requests to discontinue semaglutide by 24 weeks after starting semaglutide administration, they will be treated as a dropout group. In addition, those who wish to receive semaglutide after 48 weeks from the start of treatment will also be treated as a dropout group.
Interventions/Control_2
The other group will also receive nutritional guidance (once/month) and exercise guidance (once/month) as well as semaglutide administration (once/week) as a regular obesity outpatient clinic. After that, counseling (once/month) will be provided as cognitive behavioral therapy. The dose of semaglutide will be increased and discontinued in the same manner as in the first group, counseling will be discontinued when semaglutide is discontinued, and various tests will be conducted 24 weeks after discontinuation.
We will analyze the evaluation items between the two groups, such as the rate of change in body weight from the time semaglutide was discontinued until 24 weeks after discontinuation.
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
Patients who meet all of the following criteria are eligible.
1) Patients who are 18 years of age or older at the time of obtaining consent
2) Outpatient/Inpatient, OutpatientO
3) Gender, Any
4) BMI is 27 kg/m2 or more
5) Complicated by hypertension or dyslipidemia
6) Those who are about to start drug treatment with semaglutide.
7) Those who meet the semaglutide package insert. Despite diet,exercise therapy, sufficient effects are not obtained and Have two or more obesity-related health disorders.
8) Patients who have received sufficient explanation and consent of their own free will to participate in this study with full understanding.
Key exclusion criteria
Patients who fall under any of the following will not be included in this study.
1) Patients with severe hepatic or renal dysfunction
2) Pregnant and lactating women
3) Patients with malignant tumor
4) Patients with severe heart failure/arrhythmia
5) Patients with secondary obesity due to endocrine (hormone) or other drugs, etc.
6) Patients with a history of hypersensitivity to semaglutide
7) Patients with diabetic ketoacidosis, diabetic coma or precoma, type 1 diabetes
8) Severe infections in patients with type 2 diabetes, conditions requiring emergency surgery, etc.
9) Other patients deemed unsuitable as research subjects by the research director
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KAZUHISA |
| Middle name | |
| Last name | TAKAHASHI |
Organization
kansai medical university
Division name
Department medicine II
Zip code
5731010
Address
Shinmachi 2 Chome, Hirakata City, Osaka, Japan
TEL
81(0)72-804-0101
takakazu@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | KAZUHISA |
| Middle name | |
| Last name | TAKAHASHI |
Organization
kansai medical university
Division name
Department medicine II
Zip code
5731010
Address
Shinmachi 2 Chome, Hirakata City, Osaka, Japan
TEL
81(0)72-804-0101
Homepage URL
takakazu@hirakata.kmu.ac.jp
Sponsor or person
Institute
kansai medical university
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
Kansai Medical University Center for Ethical Review
Address
Shinmachi 2 Chome, Hirakata City, Osaka, Japan
Tel
072-804-2440
rinriirb@hirakata.kmu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
| 2024 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 02 | Month | 02 | 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
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060478
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