Bariatric Surgery CandidateNCT06299085
Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover.
A study testing 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery. in people with Bariatric Surgery Candidate, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Alcohol or drug abuse.
- Previous bariatric surgery.
- Severe psychological-psychiatric disorders.
- Difficulty adhering to the protocol due to language barriers or other reasons.
About this study
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.
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Two timepoints: pre-admission before bariatric surgery and 12 months after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299085
- Sponsor's protocol ID
- OSTEO-BS (L4191)
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06299085
- Acronym / sponsor ID
- OSTEO-BS (L4191)
- Conditions
- Bariatric Surgery Candidate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 50 adult patients suffering from severe or morbid obesity | Other | 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | 50 adult patients suffering from severe or morbid obesity |
Primary outcome
Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery.
Time frame: Two timepoints: pre-admission before bariatric surgery and 12 months after.
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.
1 secondary outcome
Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods.
Time frame: Two timepoints: pre-admission before bariatric surgery and 12 months after.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery. in people with Bariatric Surgery Candidate, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery. (time frame: Two timepoints: pre-admission before bariatric surgery and 12 months after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.