Can Pre-operative Lean Mass Predict Weight Loss After Roux-en-Y Gastric Bypass?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Geneva
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Correlation between Fat-free mass (FFM) and weight loss following RYGB
Study Overview
Brief Summary
The goal of this observational study is to evaluate whether preoperative fat-free mass predicts post-operative weight loss in patients undergoing Roux-En-Y gastric bypass. The primary objective of this study is to evaluate whether preoperative fat-free mass predicts weight loss in the two years following RYGB.
The investigators will collect the following data, assessed as part of routine follow-up:
- height, weight, hip and waist circumferences
- body composition by bioimpedance analysis and dual energy-X-ray absorptiometry
- Muscle strength and physical activity
- Nutritional parameters: resting energy expenditure, eating behavior and digestive tolerance", plasma micronutrient status. .
- Cardiovascular risk factors: fasting glucose, blood levels of Hb1Ac, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, blood pressure
- Co-morbidities: joint pain and arthritis, sleep apnea, gastro-oesophageal reflux, metabolic dysfunction-associated fatty liver disease (MAFLD), cancer, stroke, heart attack.
Quality of life: quality of life by the "Bariatric Analysis and Reporting Outcome (BAROS) questionnaire", symptoms of dumping syndrome by the "Sigstad diagnostic score system" Birthdate, birthweight and term of their children
Detailed Description
This study is prospective but the investigators will also use the retrospective data of the patients who underwent bariatric surgery before the acceptance of the study, with their informed consent.
The investigators will collect the following data, assessed as part of routine follow-up:
Preoperatively:
- medical history
- height, weight, hip and waist circumferences
- body composition by bioimpedance analysis (BIA) and dual energy-X-ray absorptiometry (DXA)
- handgrip strength
- sarcopenia questionnaire (SARC-F)
- physical activity questionnaire (IPAQ)
- resting energy expenditure by indirect calorimetry
- eating behaviour: duration of meals, hyperphagia, snacking, compulsions, and cognitive restrictions as variables dichotomized as yes or no, and hunger and satiety each through a visual analogue scale, where 0 corresponds to "no hunger or good satiety" and 10 to "big hunger or no satiety"
- digestion symptoms: frequency of vomiting and of bowel movements
- Binge eating questionnaire
- blood pressure
- blood sample
- co-morbidities
- results of liver ultrasound, gastric endoscopy
- quality of life questionnaire (BAROS), Dumping questionnaire (Sigstad)
- blood and tissue biobanking
These assessments will be repeated after surgery at the frequency indicated below:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥ 18 years AND
- •Meeting inclusion criteria for RYGB (www.smob.ch): BMI ≥35 kg/m2, failure of weight-reducing programs over 2 years (for patients with a BMI ≥50 kg/m2, 1 year), understanding of the necessity to change the lifestyle and eating habits post-operatively, signed consent for lifelong post-operative follow-up in a recognized bariatric center AND
- •Scheduled RYGB at the HUG OR previous RYGB at the HUG with a present follow-up in Clinical Nutrition and dietetics at the HUG AND
- •Understanding French
Exclusion Criteria
- •Inability or refusal to give consent.
- •Planification for another type of bariatric surgery than RYGB
- •Contra-indications to bariatric surgery as stated under www.smob.ch: insufficient nutritional knowledge in nutrition to lose weight, pregnancy, kidney failure (Creatinine ≥ 300 umol/l without dialysis, Crohn's disease, active cancer or remission < 2 years, active psychiatric disease, substance abuse (alcohol, cannabis, opioids), absence of compliance, lack of understanding of the requirements and necessary lifestyle changes reported by physician or dietician.
Arms & Interventions
Patients with scheduled RYGB at the Geneva University Hospitals
Morbidly obese patients scheduled for Roux-en-Y gastric bypass
Outcomes
Primary Outcomes
Correlation between Fat-free mass (FFM) and weight loss following RYGB
Time Frame: 2 years
FFM and lean body mass measurement using BIA and DXA, respectively
Evolution of body composition in the two years after bariatric surgery
Time Frame: 5 years
Measurments of body composition by dual energy X-ray absorptiometry before gastric bypass and yearly after gastric bypass
Secondary Outcomes
No secondary outcomes reported
Investigators
Genton Graf Laurence
Professor
University Hospital, Geneva