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

NCT06299085 | Not Yet Recruiting DMC

• 1 other identifier: OSTEO-BS (L4191)
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods.

  Two timepoints: pre-admission before bariatric surgery and 12 months after.

Study Arms (1)

50 adult patients suffering from severe or morbid obesity

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.

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

Interventions

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

50 adult patients suffering from severe or morbid obesity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 7, 2024
• Study Start: March 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: March 1, 2026
• Last Updated: March 7, 2024

Record last verified: 2023-11