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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bariatric Surgery Candidate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No