NCT07565051

Recruiting

Can Pre-operative Lean Mass Predict Weight Loss After Roux-e...

University Hospital, Geneva Source

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Other study identifiers

Sponsor study identifier

2024-02136

Study Type

observational

Estimated enrollment

91

Locations

1 country

Sites

1

Timeline

Study Start

August 18, 2025

Actual (reported)

Primary Completion

August 18, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

August 18, 2032

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 91 participants
Study completion date: August 18, 2032
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 18, 2025
Actual (reported)
First Submitted
April 27, 2026
Actual (reported)
First Posted
May 4, 2026
Actual (reported)
Primary Completion
August 18, 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 18, 2032
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: May 8, 2026
Status Verified: April 2026
Last Update Submitted: May 4, 2026

Conditions

Morbid Obesity Requiring Bariatric Surgery

Keywords

obesitygastric bypassbody compositionbone mineral densityhandgrip strengthsarcopenic obesity

Outcome Measures

Primary Outcomes (2)

Correlation between Fat-free mass (FFM) and weight loss following RYGB
FFM and lean body mass measurement using BIA and DXA, respectively
2 years
Evolution of body composition in the two years after bariatric surgery
Measurments of body composition by dual energy X-ray absorptiometry before gastric bypass and yearly after gastric bypass
5 years

Study Arms (1)

Patients with scheduled RYGB at the Geneva University Hospitals

Morbidly obese patients scheduled for Roux-en-Y gastric bypass

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients with scheduled gastric bypass at the Geneva University Hospitals (HUG)

You may qualify if:

Patients ≥ 18 years AND

Sponsors & Collaborators

University Hospital, Geneva
Otherlead

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1205, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood biobank and gastric and intestinal tissue biobank

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Laurence Genton, MD

CONTACT

0041 79 553 34 84 laurence.genton@hug.ch

Laure Wilmart-Beck

CONTACT

0041 22 372 93 49

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: OTHER
Target Duration: 5 Years
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

August 18, 2025

Actual (reported)

Primary Completion

August 18, 2027

Estimated

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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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

laure.wilmart@hug.ch

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

August 18, 2032

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

May 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07565051
Data provider: ClinicalTrials.gov
Source updated: 2026-05-08
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:46 UTC

Locations

CH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Patients with scheduled RYGB at the Geneva University Hospitals

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations