obesity obesity
Conditions
Interventions
Under general anaesthesia, a titanium clip covered with silicone is applied to the greater curvature of the stomach from the outside via laparoscopy (restrictive surgery involving surgical fixation to
Sponsors
Takashi Oshiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older at the time of consent acquisition 2. Patients with obesity 3. Individuals with one or more of the following obesity related health conditions: Type 2 diabetes, Hypertension, Dyslipidaemia, Non alcoholic fatty liver disease, Ostructive sleep apnoea syndrome . 4. Patients who, after receiving full explanation regarding participation in this study, provided written consent of their own free will based on sufficient understanding. 5. Patient who has a history of internal medical treatment for more than 6 months with insufficient therapeutic effect at the time of obtaining consent. 6. Outpatients who fully understand the importance of nutritional guidance and obesity treatment, and who are able to attend outpatient appointments and participate in online consultations according to the study schedule.
Exclusion criteria
Exclusion criteria: 1. Individuals with severe heart disease, respiratory disease, liver disease, or kidney disease 2. Individuals with structural abnormalities of the stomach, such as gastrointestinal strictures or gastric ulcers 3. Individuals who are currently pregnant or may be pregnant 4. Individuals judged to have impaired decision making capacity due to mental illness 5.Individuals for whom the principal investigator or co investigator determines that B-Clamp placement is technically difficult 6. Individuals with a history of severe drug allergies,metal allergies (titanium), such as anaphylactic shock, or a history of severe adverse reactions 7. Other individuals deemed unsuitable for participation in this study by the principal investigator or co investigator, or other individuals deemed unsuitable by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and proportion of adverse events and complications | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Weight related indicators (2) Glucose metabolism related indicators (3) Lipid metabolism related indicators (4) Liver function-related indicators (5) Blood pressure-related indicators (6)Sleep apnea-related index AHI (apnea-hypopnea index) (7) Changes in visceral fat mass (8) Quality of life (QOL) and patient satisfaction | — |
Contacts
Public ContactOshiro Takashi
The Jikei University School of Medicine
Outcome results
None listed