Can Pre-operative Lean Mass Predict Weight Loss After Roux-en-Y Gastric Bypass?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Geneva
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
91 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov