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

Bariatric Surgery Candidate Clinical Trial

— MMS-CB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558360
• Other study ID #: CHD 048-17
• Status: Recruiting
• Start date: October 15, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2021
• Source: Centre Hospitalier Departemental Vendee
• Contact: François ETCHEVERRIGARAY, PharmD
• Phone: +33 2 51 44 65 72
• Email: francois.etcheverrigaray[@]chd-vendee.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Weight Loss

Intervention

Diagnostic Test:
• Impedance measurement
Measurement of dry lean body mass berfore bariatric surgery by impedance measurement.

Locations

Country	Name	City	State
France	Centre Hospitalier Departemental Vendée	La Roche sur Yon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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