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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299085
• Other study ID #: OSTEO-BS (L4191)
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: November 2023
• Source: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 1, 2026
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.