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Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover.

NCT06299085 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-07

No results posted yet for this study

Summary

By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality.

Conditions

  • Bariatric Surgery Candidate

Interventions

OTHER

50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery.

50 adult patients suffering from severe or morbid obesity (BMI ≥ 35 kg/m2 in the presence of comorbidities and BMI ≥ 40 kg/m2, respectively), male and female, candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass). Two timepoints: T0 (pre-hospitalization) and T1 (follow-up 12 months +/- 1 month). Expected assessments at T0 and T1: * Blood chemistry tests to monitor metabolic markers involved in dietary and metabolic changes. * Bone densitometry for body composition analysis (DEXA). * Analysis of pre-intervention walking and the ability to recover motor activity after bariatric surgery using gait analysis.

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-10-31
Completion
2026-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299085 on ClinicalTrials.gov