Clinical trial NCT06299085: Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover.
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bariatric Surgery Candidate
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The minimum sample size was determined by considering the circulating levels of gastro-entero hormones (PYY, ghrelin, GLP-1, GIP), adipokines (leptin and adiponectin) and hormones associated with the anabolism of muscle and bone tissue (insulin). as primary endpoints; the highest calculated sample size obtained for ghrelin levels was used for the purposes of this study.

The calculation was performed using G\*Power software (v3.1.9.7) assuming a type I error (α error) of 0.05, a Power (1-β error) of 0.8, an effect size of 0.44.

The resulting minimum sample size is 42 patients. Taking into account the presence of any drop-outs, 20% more patients will be considered, for a total of 50 patients to be enrolled.
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery.
timeFrame: Two timepoints: pre-admission before bariatric surgery and 12 months after.
Secondary outcomes:
measure: Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods.
timeFrame: Two timepoints: pre-admission before bariatric surgery and 12 months after.
Other outcomes:
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Study officials:
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