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

Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to the Modification of Body Composition and Bone Turnover After Surgery.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Other: 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery.

Detailed Description

To date, there are no studies in scientific literature aimed at identifying the hormonal mechanisms that could contribute to increased bone turnover in patients undergoing bariatric surgery. All randomized controlled trials conducted to date have focused on nutritional factor deficiency (vitamin D3, calcium and protein), mechanical unloading and reduction of adiposity at the bone marrow level.

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 and ≤ 60 years.
• BMI (Body Mass Index: expressed as weight ratio in kg/height in m2) ≥ 35 kg/m2 with comorbidities or BMI ≥ 40 Kg/m2 without comorbidities.
• Absence of diagnosis of primary obesity.
• Absence of medical-psychiatric contraindications.
• Previous diet therapy and/or pharmacological history verified.
• Signing of the informed consent for the study.
• Patients who are clinical candidates for bariatric surgery (Sleeve Gastrectomy and Roux-en-Y Gastric Bypass).

Exclusion Criteria:

• Presence of chronic diseases of the digestive system, such as chronic intestinal diseases, malabsorption syndrome, diverticulosis of the colon.
• Current pregnancy and/or breastfeeding via self-declaration.
• Subjects suffering from endocrine pathologies (e.g. Cushing's disease, uncontrolled thyroid disease).
• Presence of known renal insufficiency or creatinine levels above 1.8 mg/dl and eGFR < 60 ml/min.
• Presence of chronic liver disease or ALT and AST levels above two standard deviations from normal levels.
• Presence of malignant pathology.
• Alcohol or drug abuse.
• Previous bariatric surgery.
• Severe psychological-psychiatric disorders.
• Difficulty adhering to the protocol due to language barriers or other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 50 adult patients suffering from severe or morbid obesity; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery.	Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery by evaluating the circulating levels of gastro-entero hormones, adipokines and hormones associated with anabolism of muscle and bone tissue.	Two timepoints: pre-admission before bariatric surgery and 12 months after.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods.	Analysis of circulating levels of hormones linked to the anabolism of muscle and bone tissue such as estrogens, androgens and insulin. Evaluation of the bone health status of patients pre- and post-bariatric surgery through: Dual-Energy x-Ray (DEXA) for body composition analysis;; measurement of biomarkers of bone turnover and parathyroid hormone levels;; evaluation of the nutritional status of patients. Analysis of pre-intervention walking and the ability to recover motor activity after bariatric surgery using gait analysis. Through Gait Analysis it is possible to analyze body movement and muscle activity.	Two timepoints: pre-admission before bariatric surgery and 12 months after.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OSTEO-BS (L4191)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No