Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery. (MMS-CB)

Bariatric surgery is currently the only method that has proven long-term effectiveness in obesity. Although the benefit of physical activity on weight loss has been demonstrated, no correlation has ever been reported between preoperative lean body mass and postoperative weight loss. Dry lean mass is probably an essential prognostic factor for the effectiveness of bariatric surgery.

The main objective of this study is to define a preoperative dry lean body mass threshold as a worst prognostic factor for weight loss one year after bariatric surgery.

The management of patients included in this study was modelled on the management usually offered to patients followed for the same pathology in the diabeto-endocrinology department. There are no study-specific examinations that are not part of current practice.

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Diagnostic test: Impedance measurement

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: François ETCHEVERRIGARAY, PharmD; Phone Number: +33 2 51 44 65 72; Email: francois.etcheverrigaray@chd-vendee.fr

Study Locations

• France
  • La Roche sur Yon, France, 85925
    • Recruiting
    • Centre Hospitalier Departemental Vendee
    • Contact: François ETCHEVERRIGARAY; Email: francois.etcheverrigaray@chd-vendee.fr
    • Principal Investigator: Barbara FEIGEL-GUILLER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting (or having presented since 2014) an obesity with a bariatric surgery project and followed by endocrinologist doctors.

Description

Inclusion Criteria:

• BMI ≥ 40 or BMI ≥ 35 kg/m2 and a complication that can be improved after bariatric surgery: cardiovascular disease including hypertension, severe metabolic disorder including type 2 diabetes, sleep apnea syndrome or other severe respiratory disorder, hepatic steatosis, disabling osteoarticular disease.
• Patient requiring bariatric surgery (sleeve-gastrectomy or gastric bypass)
• Patient who has agreed to participate in the study
• Patient with social security coverage.

Exclusion Criteria:

• Patient with a contraindication to bariatric surgery (cognitive or psychological disorders, severe eating disorders, addiction to alcohol or psychoactive substances, contraindication to general anaesthesia, multiple history of digestive surgery, high risk of undernutrition (progressive cancer, chronic inflammatory bowel disease, cirrhosis, severe renal insufficiency...)
• Pregnant or lactating women
• Minor patient
• Major patient under tutorship, curatorship, or deprived of liberty
• Patient unable to understand protocol and / or give express consent
• Patient not affiliated with a social security system or beneficiary of such a scheme
• Patient participating in an intervention-type clinical research protocol likely to modify the evaluations of this protocol
• adults under the protection of justice

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bariatric surger; Bariatric surgery and impedance measurement	Diagnostic test: Impedance measurement; Measurement of dry lean body mass berfore bariatric surgery by impedance measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of dry lean mass in pre-operative by impedance measurement	Excess weight loss at M12: ideal weight is defined in relation to height for a BMI of 25.0 kg/m2. Excess weight is the difference between the observed weight and the ideal weight. Excess weight loss is the ratio of weight loss to excess weight.	12 months after bariatric surgery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Study Director: Barbara FEIGEL-GUILLER, MD, Centre Hospitalier Departemental Vendee

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: bariatric surgery; lean body mass
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: CHD 048-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No