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

C

Centre Hospitalier Departemental Vendee

Status

Unknown

Conditions

Bariatric Surgery Candidate

Treatments

Diagnostic Test: Impedance measurement

Study type

Observational

Funder types

Other

Identifiers

NCT03558360
CHD 048-17

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

180 participants in 1 patient group

Bariatric surger
Description:
Bariatric surgery and impedance measurement
Treatment:
Diagnostic Test: Impedance measurement

Trial contacts and locations

1

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Central trial contact

François ETCHEVERRIGARAY, PharmD

Data sourced from clinicaltrials.gov

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