UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054960 |
|---|---|
| Receipt number | R000062798 |
| Scientific Title | Efficacy and safety of gradual dose-escalation therapy of semaglutide on body weight and body composition in people with obesity: A multicenter intervention study. |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/09/18 16:35:23 |
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Basic information
Public title
Effect of semaglutide treatment on body weight and body composition in people with obesity
Acronym
SULUGA STUDY
Scientific Title
Efficacy and safety of gradual dose-escalation therapy of semaglutide on body weight and body composition in people with obesity: A multicenter intervention study.
Scientific Title:Acronym
SULUGA STUDY
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 evaluate the efficacy and safety of semaglutide treatment on body weight and body composition in people with obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Effect of semaglutide on body weight in participants with obesity
Key secondary outcomes
1. The occurrence of adverse events in obese participants with semaglutide treatment.
2. The effect of semaglutide on body composition (refer to the following) in participants with obesity.
Muscle mass, skeletal muscle mass, skeletal muscle index (SMI), body fat mass, body fat percentage, visceral fat level, basal metabolic rate, bone mineral mass, basal metabolic rate.
3. The effect of semaglutide on fingertip AGEs score in participants with obesity.
4. The effect of semaglutide on the following metabolic parameters in participants with obesity.
HbA1c, fasting blood glucose, systolic/diastolic blood pressure, lipid profile (LDL-C, HDL-C, TG), eGFR, liver function (AST, ALT, GGT), FIB-4 index, fasting insulin, fasting CPR, HOMA-R, insulinogenic index by 75g OGTT, serum protein, serum albumin, changes in medication and number of medications taken at the start of the study.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Semaglutide (Wegovy)
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
The target number of cases across all participating facilities will be 40, and will include those who meet the inclusion criteria below and do not meet the exclusion criteria below.
a) Have been diagnosed with one or more of type 2 diabetes and/or hypertension and/or dyslipidemia and are undergoing drug therapy.
b) Have a history of receiving nutritional guidance at least once every two months for at least six months based on a treatment plan.
c) Have a BMI of 35 or more or 27 or more and have two or more health disorders* that are not sufficiently effective with diet and exercise therapy.
[*Health disorders related to obesity]
1) Impaired glucose tolerance (T2DM/impaired glucose tolerance)
2) Dyslipidemia
3) Hypertension
4) Hyperuricemia/gout
5) Coronary artery disease
6) Stroke/transient ischemic attack
7) Non-alcoholic fatty liver disease
8) Menstrual abnormalities/female infertility
9) Obstructive sleep apnea syndrome/obesity hypoventilation syndrome
10) Musculoskeletal disease (osteoarthritis/spondylosis)
11) Obesity-related kidney disease
Key exclusion criteria
1. Cases with obvious infection.
2. Cases of obvious chronic inflammatory diseases such as autoimmune diseases, or cases of long-term use of steroid drugs for treatment.
3. Cases diagnosed with advanced cancer.
4. Fresh case of cerebrovascular accident (within 12 weeks of onset).
5. Cases with liver dysfunction (ALT > 3 x facility upper limit).
6. Cases with complications that are judged to seriously impede the conduct of the study, such as respiratory disease, poorly controlled heart failure, or arrhythmia.
7. Cases with a history of alcoholism or drug addiction, or cases with psychosis or psychotic symptoms that make it difficult to participate in the study.
8. In other cases where the doctor in charge of the study determines that the subject is unsuitable for the safe conduct of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsumi |
| Middle name | |
| Last name | Aso |
Organization
ASO Clinic
Division name
Director
Zip code
410-0041
Address
11-1 Tsutsui-machi, Numazu, Shizuoka
TEL
055-929-7575
info@aso-clinic.jp
Public contact
Name of contact person
| 1st name | Katsumi |
| Middle name | |
| Last name | Aso |
Organization
ASO Clinic
Division name
Secretariat
Zip code
410-0041
Address
11-1 Tsutsui-machi, Numazu, Shizuoka
TEL
055-929-7575
Homepage URL
info@aso-clinic.jp
Sponsor or person
Institute
ASO Clinic, Director
Institute
Department
Personal name
Takeshi Matsumura
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ASO Clinic
Address
11-1 Tsutsui-machi, Numazu, Shizuoka
Tel
055-929-7575
info@aso-clinic.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
熊本大学病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | 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
| 2024 | Year | 07 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062798
