Geneva University Hospitals
Geneva, Canton of Geneva, 1205, Switzerland
Location status: Recruiting
NCT Number: NCT07565051
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
Interested in participating?
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Observational
Geneva, Canton of Geneva, 1205, Switzerland
Location status: Recruiting
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:
These assessments will be repeated after surgery at the frequency indicated below:
Study sample calculation:
The investigators hypothesized, in a conservative way and based on available litterature, that the patients will decrease their lean mass by 5±10 kg within 2 years after RYGB. A sample size of 32 achieves 90% power to detect a mean of paired differences of 5 kg with an estimated standard deviation of paired differences of 10.0 and with a significance level (alpha) of 0.050 using a two-sided paired t-test.
The investigators plan to evaluate whether preoperative FFM (independent variable) predicts weight loss (dependent variable) while adjusting for age, sex, preoperative BMI category (35-40, 40-50, > 50), and FM, physical activity. This corresponds to 6 adjustment variables altogether, or 3 supplemental variables. According to the rule of Harrel that stipulates at least 10 observations per independent variables, the investigators need at least 70 participants (10*(1+6)) to perform these adjustments.
Considering a drop-out rate of 30% at 2 years, the investigators will need a sample size of: 70+30% = 91 subjects.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
FFM and lean body mass measurement using BIA and DXA, respectively
Time frame: 5 years
Measurments of body composition by dual energy X-ray absorptiometry before gastric bypass and yearly after gastric bypass
Contact information is provided by the study sponsor or research team.
Laure Wilmart-Beck
CONTACT
Laurence Genton, MD
CONTACT
University Hospital, Geneva
Other
Acronym: FLAG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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