Preoperative Dry Lean Body Mass as a Prognostic Factor fo... | NCT03558360

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

NCT03558360

Sponsor

Centre Hospitalier Departemental Vendee

Status

Unknown status

Last Update Posted

Dec 23, 2021Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Bariatric Surgery Candidate

Interventions

Impedance measurement

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2018Actual

Primary Completion Date

Apr 1, 2022Estimated

Completion Date

Sep 1, 2022Estimated

First Submitted Date

Jun 4, 2018

First Submission Date that Met QC Criteria

Jun 14, 2018

First Posted Date

Jun 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2021

Last Update Posted Date

Dec 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bariatric surger		Bariatric surgery and impedance measurement	Diagnostic Test: Impedance measurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impedance measurement	Diagnostic Test	Measurement of dry lean body mass berfore bariatric surgery by impedance measurement.	Bariatric surger

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
François ETCHEVERRIGARAY, PharmD	Contact	+33 2 51 44 65 72		francois.etcheverrigaray@chd-vendee.fr

Overall Officials

Name	Affiliation	Role
Barbara FEIGEL-GUILLER, MD	Centre Hospitalier Départemental Vendée	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Departemental Vendée	Recruiting	La Roche-sur-Yon		85925	France

Type	Date	Date Unknown
Release	May 21, 2026
Reset	Jun 16, 2026