MedDataX Logo

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

NCT ID: NCT03558360

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery Candidate

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

lean body mass bariatric surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bariatric surger

Bariatric surgery and impedance measurement

Impedance measurement

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Impedance measurement

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara FEIGEL-GUILLER, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Départemental Vendée

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Departemental Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

François ETCHEVERRIGARAY, PharmD

Role: CONTACT

Phone: +33 2 51 44 65 72

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

François ETCHEVERRIGARAY

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHD 048-17

Identifier Type: -

Identifier Source: org_study_id