CClinicalTrials.gg
Status unknownNCT03558360MMS-CBUpdated Dec 23, 2021

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

An observational study in Bariatric Surgery Candidate, sponsored by Centre Hospitalier Departemental Vendee. Status unknown at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-12-23.

Sponsored by Centre Hospitalier Departemental Vendee · Observational

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
180
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Bariatric Surgery Candidate

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Keywords

  • lean body mass
  • bariatric surgery
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 278 are open to participants now.

This study's planned enrollment of 180 is above the median of 92 across 219 observational studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Centre Hospitalier Departemental Vendee is the lead sponsor of 81 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
180 participants (estimated)
Patient registry
No

Groups and cohorts

  • Bariatric surger

    Bariatric surgery and impedance measurement

    Diagnostic Test: Impedance measurement

Interventions

  • Diagnostic testImpedance measurement

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

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What researchers measure

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.

    Time frame: 12 months after bariatric surgery

07

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier Departemental Vendée
    La Roche sur Yon, 85925, France
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03558360
Lead sponsor
Centre Hospitalier Departemental Vendee
Responsible party
Sponsor
First posted
Jun 15, 2018
Start date
Oct 15, 2018
Primary completion
Apr 1, 2022 (estimated)
Completion
Sep 1, 2022 (estimated)
Last update
Dec 23, 2021

Study contacts

François ETCHEVERRIGARAY, PharmD
Contact
francois.etcheverrigaray@chd-vendee.fr
+33 2 51 44 65 72
Barbara FEIGEL-GUILLER, MD
study director · Centre Hospitalier Départemental Vendée

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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