Obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Resistance to medical treatment for more than 6 months; BMI >= 35 kg/m2; One of the complications including diabetes, hypertension, dyslipidemia, sleep apnea syndrome. or 2) Resistance to medical treatment for more than 6 months; 34.9 >= BMI >= 32.5 kg/m2 and one of the followings: diabetes (HbA1c >= 8.4%); uncontrollable hypertension (systolic blood pressure >= 160 under the treatment with antihypertensive drug); dyslipidemia (LDL >= 140 mg/dl or non-HDL cholesterol >= 170 mg/dl under the medication for more than 6 months); sleep apnea syndrome (AHI >= 30).
Exclusion criteria
Exclusion criteria: 1) Respiratory failure: AHI >= 30. 2) Renal function: Cr >= 2.0, GFR < 30. 3) Compliance: impossible to stop smoking for 4 weeks. 4) Severe liver dysfunction. 5) Mental diseases with unstable symptoms. 6) Pregnant woman, Lactating woman, woman predicting pregnancy. 7) Patients that doctors judged as unsuitable for surgery. 8) Malignancies, Organic diseases in the gastrointestinal tract, Neurodegenerative diseases, Metabolic disease except for diabetes. 9) Past surgery of esophagus or stomach. 10) H. pylori eradication within 6 months. 11) Medication: prokinetics, acid suppressant, antidepressant, psychotropic drug. Permit to enroll, if possible to stop those medications for more than 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of obesity surgery on gastric motility | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of obesity surgery on QOL and glucose metabolism | — |
Countries
Japan
Contacts
Hyogo College of Medicine Division of Gastroenterology and Hepatology