People living with obesity intensive medical therapy, very low-calorie diet, Roux-en-Y gastric bypass, sleeve gastrectomy, body composition, gut microbiota, diabetes remission, type 2 diabetes
Conditions
Interventions
People living with obesity who will undergo bariatric surgery (LRYGB, LSG or intragastric balloon). ,People living with obesity who will receive Intensive medical therapy including diet, exercise, nu
preference and physician judgement.
Treatment,Treatment
Bariatric,Intensive Medical Therapy
Sponsors
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
15 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Obese subjects who will undergo bariatric surgery or receive intensive medical therapy 2.Age 15-70 years 3.ability and willingness to provided informed written consent
Exclusion criteria
Exclusion criteria: 1. End-stage disease such as cancer, cirrhosis Child-Pugh C, or critical/acute illness, 2. Type 1 diabetes mellitus, 3. Use of antibiotics in the previous month, 4. Use of probiotic or prebiotic supplement in the form of tablet or sachet in the previous 14 days, 5. Pregnancy or breast-feeding, 6. Substance abuse, 7. Uncontrolled psychiatric disorders and eating disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in body weight From baseline and at each follow up visit (2-4weeks, 2-month, 3-month, 6-month, 12-month, 18-month, 24-month, then yearly) Weight in kg, percent weight loss, percent excess weight loss, percent BMI loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Gut microbiota pattern From baseline and at each follow up visit Measured by 16S ribosomal RNA (rRNA) gene sequencing or Nanopores from the fecal samples,Liver steatosis and liver stiffness From baseline and at each follow up visit MRI and FibroScan,Blood pressure, Heart rate, pulse rate From baseline and at each follow up visit vital signs,Fasting insulin, C-peptide, adiponectin and others biochemical test From baseline and at each follow up visit Blood test,Insulin resistance From baseline and at each follow up visit Blood test,FPG, A1C, lipid profile, proteinurea, microalbuminurea, and others biochemical tests From baseline and at each follow up visit Blood test, urine test,Health-related quality of life From baseline and at each follow up visit Measured by the EQ-5D-5L questionnaire,Depression From baseline and at each follow up visit Measured by the PHQ-9 questionnaire,Resting energy expenditure From baseline and at each follow up visit Indirect calorimetry,nutritinal status and micronutrients status From baseline and at each follow up visit clinical and blood test,Body composition From baseline and at each follow up visit Bioelectrical impedance and/or Dual Energy X-ray absorptiometry,Bone mineral density baseline and then yearly Dual Energy Xray absorptiometry,Diabetes and comorbidities improvement (including risk of cardiovascular diseases) at each follow-up visit clinical and blood test | — |
Countries
Thailand
Contacts
Public ContactPrapimporn Shantavasinkul
Faculty of Medicine Ramathibodi, Mahidol University
Outcome results
None listed