An interventional study of Very low-calorie diet and Bariatric surgery in Obesity, sponsored by Mahidol University. Enrolling by invitation at 1 site in Thailand. Open to participants aged 15 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-05.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
Obesity is a chronic disease characterized by the excessive accumulation of fat in body and it continues to be a major public health problem worldwide. Treatment options for obesity include lifestyle modification, pharmacotherapy and bariatric surgery. Bariatric surgery is a highly effective treatment for obesity and results in rapid and sustained weight loss. Also, it significantly alters gut microbiota composition and function. A very low-calorie diet (VLCD) is a rapid weight loss program which calorie intake is severely restricted (\< 800 kcal/day). It has been shown to be very effective to induce rapid weight loss and result in comorbidities resolution similar to bariatric surgery. Therefore, this study was aimed to study the effects of 12-week VLCD compare to bariatric surgery (Laparoscopic Roux-en-Y gastric bypass (LRYGB) or Laparoscopic Sleeve Gastrectomy (LSG)) on weight loss, body composition, gut microbiota pattern and other metabolic parameters.
The study will include obese patients (body mass index; BMI ≥ 37.5 kg/m2 or BMI ≥ 32.5 kg/m2 with comorbidities), aged 15-65 years at Ramathibodi Hospital, Thailand. The VLCD group will received total diet replacement for 12 weeks and the bariatric surgery group will undergo LRYGB or LSG. Study participants in both groups will be matched according to their age, sex, body mass index (BMI) and diabetic status. Body weight reduction and body composition, gut microbiota pattern, liver stiffness and steatosis, glycemic and other metabolic parameters (glucose, insulin, c-peptide, lipid profile, liver function test, kidney function test, complete blood count, electrolyte blood test, thyroid function tests, serum ketone and adiponectin), health-related quality of life, depression score and twenty-four-hour diet recall and physical activity will be assessed at baseline and at month 1, 3, 6, 9 and 12.
Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the very low-calorie diet group will be prescribed a very low-calorie diet (meal replacement) for 12 weeks, then the patients will be monitored up to 1 year
Other: Very low-calorie diet
Patients in the bariatric surgery group will be undergone bariatric surgery LRYGB and will be follow-up according the current guideline
Procedure: Bariatric surgery
Meal replacement (800 kcal/day, protein 90 g/day)
Bariatric surgery will be performed by single surgeon at Ramathibodi Hospital Mahidol University, Thailand. Postoperative diet progression according to the current guideline will be prescribed from early post-op period to 1 year after surgery
Changes in body weight
Weight in kg
Time frame: From baseline to 12 weeks
Body Composition
The percentage of body fat and skeleton muscle mass
Time frame: From baseline to 12 weeks
Gut microbiota pattern
Measured by 16S ribosomal RNA (rRNA) gene sequencing on the fecal samples
Time frame: From baseline to 12 weeks
Liver stiffness
Measured by FibroScan® instrument
Time frame: From baseline to 12 weeks
Liver steatosis
Measured by FibroScan® instrument
Time frame: From baseline to 12 weeks
Blood pressure
Systolic and diastolic blood pressure
Time frame: From baseline to 12 weeks
Fasting plasma glucose
Measured in mg/dl
Time frame: From baseline to 12 weeks
Hemoglobin A1c
Measured in %
Time frame: From baseline to 12 weeks
Fasting insulin
Measured in μIU/l
Time frame: From baseline to 12 weeks
Insulin resistance
Measured by the homeostatic model of insulin resistance (HOMA-IR)
Time frame: From baseline to 12 weeks
Triglyceride
Measured in mg/dl
Time frame: From baseline to 12 weeks
Total cholesterol
Measured in mg/dl
Time frame: From baseline to 12 weeks
LDL-cholesterol
Measured in mg/dl
Time frame: From baseline to 12 weeks
HDL-cholesterol
Measured in mg/dl
Time frame: From baseline to 12 weeks
Health-related quality of life
Measured by the EQ-5D-5L questionnaire
Time frame: From baseline to 12 weeks
Depression
Measured by the PHQ-9 questionnaire
Time frame: From baseline to 12 weeks
Plan to share: No
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Mahidol University