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

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

Status: Not yet enrolling

Conditions: Bariatric Surgery Candidate

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06299085

OSTEO-BS (L4191)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

50 adult patients suffering from severe or morbid obesity

Other group

Description:

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.

Treatment:

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