Obese patients with metabolic abonormalities
Conditions
Interventions
bariatric surgery
Sponsors
Kanazawa University Graduate School of Medical Sciences Department of Endocrinology and Metabolism
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)BMI 35 kg/m2 or more 2)Patients with metabolic disorders 3)at least absolved 6 months of failed conservative treatment for morbid obesity 4)Age over 20 years old 5)participants provided written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients who participated in other clinical studies (trials) within 3 months before the study 2)Inability to participate in the study as assessed by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement in histlogic features of NAFLD,as assessed with a composite of standardized scores for steatosis,lobular inflammation,hepatocellular ballooning,and fibrosis.Disease activity is assessed with the nonalcoholic fatty liver disease activity score,which is based on a standardized grading system for steatosis(on a scale of 0 to 3),lobular inflammation(on a scale of 0 to 3),and hepatocellular ballooning(on a scale of 0 to 2),with higher scores indicating increasing severity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in liver enzymes Change from baseline in body composition Change from baseline in fasting plasma glucose level and glucose metabolism assessed with arginine tolerance test Changes from baseline in organ-specific insulin sensitivity and glucagon response during a euglycemic hyperinsulinemic clamp study Change from baseline in lipid profile Change from baseline in renal function and electrolyte balances Change from baseline in hepatokine (Selenoprotein P, LECT2) levels Change from baseline in organ-specific fat accumulation Change from baseline in oxidative and non-oxidative glucose disposal Change from baseline in respiratory quotients Change from baseline in energy expenditure Change from baseline in autonomic nerve function. This is performed by power-spectrum analyses of heart rate variability Changes from baseline in minerals and bone metabolism Changes from baseline in endothelial functions Factors associated with the changes in autonomic nerve function, organ-specific fat accumulation, and glucagon response. Changes from baseline in gene expression profiles in the liver and blood cells Changes from baseline in microRNAs and exosome contents Epigenomic changes from baseline in genes of the liver and blood cells Changes in severity index of sleep apnea by sleeping polysomnography Improvement of QOL evaluation by SF-36 questionnaire Motor effect analysis by I-PAQ Nutritional assessment by meal behavior questionnaire and FFQg | — |
Countries
Japan
Contacts
Public ContactYumie Takeshita
Kanazawa University Graduate School of Medical Sciences Department of Endocrinology and Metabolism
Outcome results
None listed