Preoperative Dry Lean Body Mass as a Prognostic Factor for Excess Weight Loss After Bariatric Surgery.

NCT03558360 | Unknown

• 1 other identifier: CHD 048-17
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery Candidate

Keywords

lean body mass; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bariatric surger

Bariatric surgery and impedance measurement

Diagnostic Test: Impedance measurement

Interventions

Impedance measurement DIAGNOSTIC_TEST

Measurement of dry lean body mass berfore bariatric surgery by impedance measurement.

Bariatric surger

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (1)

Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, 85925, France

RECRUITING

Study Officials

• Barbara FEIGEL-GUILLER, MD

  Centre Hospitalier Départemental Vendée

  STUDY DIRECTOR

Central Study Contacts

François ETCHEVERRIGARAY, PharmD

CONTACT

+33 2 51 44 65 72; francois.etcheverrigaray@chd-vendee.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: October 15, 2018
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

FR (1)