Obesity
Conditions
Interventions
Two arm cross-over trial Arm1: A swallowable balloon capsule (volume 400ml filled with CO2) implanted for 4 months in the stomach Arm2: A placebo balloon capsule ( not inflatable due to holes in i
Sponsors
Sapporo Orthopaedics and Cardiovascular Hospital
Sapporo Shiroishi Memorial Hospital, Otaru Ekisaikai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with a BMI more than 30 2.Patients with a BMI between 25 and 30 who have a past history of, or are presently having treatment for diabetes, hyperlipidemia (LDL-C over 200), angina pectoris, cerebral infarction or NASH (Non- alcoholic steatohepatitis).
Exclusion criteria
Exclusion criteria: 1. Patients undergoing insulin therapy or patients with conditions such as chronic heart failure or chronic renal failure, which would make it very difficult for them to improve physical activity levels. 2. Patients who cannot ingest capsules 3. Patients who have a rubber allergy 4. Patients who have their digestive tract altered by surgery or have a high risk of ileus or stenosis due to stricture in the gastrointestinal tract. 5. Patients who have an implant such as a cardiac pace-maker. 6. Patients who will not allow the doctor to perform an endoscopic procedure in an emergency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reducing rate of the excess body weight before and after the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reducing the amount of internal fat tissue which will be evaluated by a CT scan before and after the trial. 2. Efficacy of glucose tolerance and hyperlipidemia 16 weeks after ingestion 3.Changes in the microbiota in the gut using 16S rRNA fecal analysis 16 weeks after ingestion 4.Evaluation of adverse reactions | — |
Countries
Japan
Contacts
Public ContactMasami Sasaki
Sapporo Orthopaedics and Cardiovascular Hospital Committee for Clinical Trial and Institutional Review Board
Outcome results
None listed