Obesity and OverweightNCT06664580
Nutritional Health and Satisfaction After Bariatric Surgery: a Five-Year Retrospective Study
An observational study of Obesity and Overweight and Nutritional Deficiency, run by San Raffaele Telematic University.
Trial summary
A retrospective study analyzing long-term outcomes of metabolic bariatric surgery (MBS) with a focus on weight loss, nutritional deficiencies, and patient satisfaction over a five-year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity and Overweight, Nutritional Deficiency, Bariatric Surgery
- What is being tested?
- Metabolic Bariatric Surgery Procedures
- How many people
- 249 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jan 2024
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who underwent metabolic bariatric surgery, including LSG and RYGB, at a specialized center, with a focus on long-term outcomes in weight maintenance, nutritional health, and patient satisfaction
Inclusion criteria: Patients aged 18 to 65 years who underwent metabolic bariatric surgery (MBS) at the Specialized Bariatric Center between 2012 and 2017, with a follow-up period of at least five years post-surgery.
Exclusion criteria: Individuals with a history of alcoholism, severe social anxiety impacting post-operative care participation, recent neoplastic disease diagnoses, neurocognitive disorders, or other systemic diseases potentially affecting quality of life and long-term outcomes.
About this study
Official title: Enhancing Nutritional Health and Patient Satisfaction Five Years After Metabolic Bariatric Surgery with Targeted Supplementation
A retrospective study analyzing long-term outcomes of metabolic bariatric surgery (MBS) with a focus on weight loss, nutritional deficiencies, and patient satisfaction over a five-year follow-up. This study evaluates outcomes for different surgical procedures, including Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB), and other MBS techniques. The findings aim to provide insight into optimal nutritional management and patient care following bariatric surgery.
Read the detailed description
This study retrospectively examines 249 patients who underwent metabolic bariatric surgery at a specialized center between 2012 and 2017. It evaluates long-term outcomes including weight loss, excess weight loss percentage (%EWL), and nutritional deficiencies, with a specific focus on the effectiveness of targeted supplementation protocols to improve nutritional health post-surgery. The study analyzes different surgical procedures, including LSG, RYGB, and others, comparing primary and revision surgeries. Nutritional deficiencies in essential vitamins and minerals are assessed, highlighting the need for individualized supplementation based on the type of surgery and patient adherence.
Key objectives include:
- Assessing long-term weight loss and maintenance across different MBS procedures.
- Identifying the prevalence of nutritional deficiencies, particularly for iron, vitamin D, and B12.
- Evaluating patient satisfaction and quality of life improvements following MBS.
Data were collected from electronic clinical records and include anthropometric data, biochemical markers, and self-reported supplement use. Findings emphasize the importance of targeted supplementation and regular monitoring to address persistent deficiencies. The study contributes to understanding optimal long-term care strategies for MBS patients and underscores the importance of personalized nutritional support post-surgery.
- Being tested
- Metabolic Bariatric Surgery Procedures
- Keywords
- Metabolic Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, Excess Weight Loss, Iron Deficiency, Vitamin D Deficiency, Quality of Life Post-Surgery, Targeted Supplementation
- Medical subject headings
- Obesity, Overweight, Malnutrition, Iron Deficiencies, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic Bariatric Surgery ProceduresOther
Also called weight, bariatric, nutrition
Observational analysis of various metabolic bariatric surgeries, including LSG, RYGB, and OAGB, focusing on long-term outcomes related to weight maintenance, nutritional health, and patient satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Post-Metabolic Bariatric Surgery Patients | A cohort of 249 patients who underwent metabolic bariatric surgery, including various procedures such as Laparoscopic Sleeve Gastrectomy (LSG) and Roux-en-Y Gastric Bypass (RYGB), with follow-up on long-term outcomes related to weight maintenance, nutritional deficiencies, and patient satisfaction Receives: Other: Metabolic Bariatric Surgery Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Excess Weight Loss (%EWL)
5 years post-surgery
Measured: The percentage of excess weight lost relative to baseline, calculated to assess long-term weight maintenance following different metabolic bariatric surgeries.
Secondary outcomes (2)
Incidence of Nutritional Deficiencies
Rate of nutritional deficiencies, specifically in iron, vitamin D, and vitamin B12, following metabolic bariatric surgery, with a focus on patients receiving targeted supplementation.
Measured: 5 years post-surgery
Patient Satisfaction and Quality of Life
Self-reported patient satisfaction and quality of life improvement post-surgery, assessed through a custom survey.
Measured: 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jan 2017
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Raffaele Telematic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Lombardo, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664580
- Sponsor's protocol ID
- 100/SR/24
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy concerns and the retrospective nature of the study, which limits consent for data sharing beyond the initial research purposes. Aggregated study results and relevant findings are available upon reasonable request.
Publications
Heusschen L, Berendsen AAM, Deden LN, Hazebroek EJ, Aarts EO. Nutritional Deficiencies 3 Years After Sleeve Gastrectomy Can Be Limited by a Specialized Multivitamin Supplement. Obes Surg. 2022 Nov;32(11):3561-3570. doi: 10.1007/s11695-022-06256-w. Epub 2022 Aug 26.
PubMed 36018421Noria SF, Shelby RD, Atkins KD, Nguyen NT, Gadde KM. Weight Regain After Bariatric Surgery: Scope of the Problem, Causes, Prevention, and Treatment. Curr Diab Rep. 2023 Mar;23(3):31-42. doi: 10.1007/s11892-023-01498-z. Epub 2023 Feb 8.
PubMed 36752995Gorini S, Camajani E, Franchi A, Cava E, Gentileschi P, Bellia A, Karav S, Sbraccia P, Caprio M, Lombardo M. Enhancing nutritional health and patient satisfaction five years after metabolic bariatric surgery with targeted supplementation. J Transl Med. 2025 Feb 21;23(1):216. doi: 10.1186/s12967-025-06224-9.
PubMed 39984967
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Nutritional Health and Patient Satisfaction Five Years After Metabolic Bariatric Surgery with Targeted Supplementation
- ClinicalTrials.gov ID
- NCT06664580
- Acronym / sponsor ID
- 100/SR/24
- Keywords
- Metabolic Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Roux-en-Y Gastric Bypass, Excess Weight Loss, Iron Deficiency, Vitamin D Deficiency, Quality of Life Post-Surgery, Targeted Supplementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- San Raffaele Telematic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 29 Oct 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.
A retrospective study analyzing long-term outcomes of metabolic bariatric surgery (MBS) with a focus on weight loss, nutritional deficiencies, and patient satisfaction over a five-year follow-up. This study evaluates outcomes for different surgical procedures, including Laparoscopic Sleeve Gastrectomy (LSG), Roux-en-Y Gastric Bypass (RYGB), and other MBS techniques. The findings aim to provide insight into optimal nutritional management and patient care following bariatric surgery.
Detailed description
This study retrospectively examines 249 patients who underwent metabolic bariatric surgery at a specialized center between 2012 and 2017. It evaluates long-term outcomes including weight loss, excess weight loss percentage (%EWL), and nutritional deficiencies, with a specific focus on the effectiveness of targeted supplementation protocols to improve nutritional health post-surgery. The study analyzes different surgical procedures, including LSG, RYGB, and others, comparing primary and revision surgeries. Nutritional deficiencies in essential vitamins and minerals are assessed, highlighting the need for individualized supplementation based on the type of surgery and patient adherence.
Key objectives include:
- Assessing long-term weight loss and maintenance across different MBS procedures.
- Identifying the prevalence of nutritional deficiencies, particularly for iron, vitamin D, and B12.
- Evaluating patient satisfaction and quality of life improvements following MBS.
Data were collected from electronic clinical records and include anthropometric data, biochemical markers, and self-reported supplement use. Findings emphasize the importance of targeted supplementation and regular monitoring to address persistent deficiencies. The study contributes to understanding optimal long-term care strategies for MBS patients and underscores the importance of personalized nutritional support post-surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Metabolic Bariatric Surgery Patients | – | Other: Metabolic Bariatric Surgery ProceduresA cohort of 249 patients who underwent metabolic bariatric surgery, including various procedures such as Laparoscopic Sleeve Gastrectomy (LSG) and Roux-en-Y Gastric Bypass (RYGB), with follow-up on long-term outcomes related to weight maintenance, nutritional deficiencies, and patient satisfaction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who underwent metabolic bariatric surgery, including LSG and RYGB, at a specialized center, with a focus on long-term outcomes in weight maintenance, nutritional health, and patient satisfaction
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 |
|---|---|---|
| Metabolic Bariatric Surgery ProceduresAlso: weight, bariatric, nutritionObservational analysis of various metabolic bariatric surgeries, including LSG, RYGB, and OAGB, focusing on long-term outcomes related to weight maintenance, nutritional health, and patient satisfaction. | Other | Post-Metabolic Bariatric Surgery Patients |
Primary outcome
Percentage of Excess Weight Loss (%EWL)
Time frame: The percentage of excess weight lost relative to baseline, calculated to assess long-term weight maintenance following different metabolic bariatric surgeries.
5 years post-surgery
2 secondary outcomes
Incidence of Nutritional Deficiencies
Time frame: 5 years post-surgery
Patient Satisfaction and Quality of Life
Time frame: 5 years post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 36018421Heusschen L, Berendsen AAM, Deden LN, Hazebroek EJ, Aarts EO. Nutritional Deficiencies 3 Years After Sleeve Gastrectomy Can Be Limited by a Specialized Multivitamin Supplement. Obes Surg. 2022 Nov;32(11):3561-3570. doi: 10.1007/s11695-022-06256-w. Epub 2022 Aug 26.
- Background: PubMed 36752995Noria SF, Shelby RD, Atkins KD, Nguyen NT, Gadde KM. Weight Regain After Bariatric Surgery: Scope of the Problem, Causes, Prevention, and Treatment. Curr Diab Rep. 2023 Mar;23(3):31-42. doi: 10.1007/s11892-023-01498-z. Epub 2023 Feb 8.
- Derived from this study: PubMed 39984967Gorini S, Camajani E, Franchi A, Cava E, Gentileschi P, Bellia A, Karav S, Sbraccia P, Caprio M, Lombardo M. Enhancing nutritional health and patient satisfaction five years after metabolic bariatric surgery with targeted supplementation. J Transl Med. 2025 Feb 21;23(1):216. doi: 10.1186/s12967-025-06224-9.
- Collaboration Agreement on: 'RETROSPECTIVE ASSESSMENT OF WEIGHT LOSS AND NUTRITIONAL DEFICIENCIES IN PATIENTS UNDERGOING BARIATRIC SURGERY' Between: Nutrition Unit, San Raffaele Telematic University (hereafter 'Unit'), e UOC Internal MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy concerns and the retrospective nature of the study, which limits consent for data sharing beyond the initial research purposes. Aggregated study results and relevant findings are available upon reasonable request.
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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?
An observational study of Obesity and Overweight and Nutritional Deficiency, run by San Raffaele Telematic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 29 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Excess Weight Loss (%EWL) (time frame: The percentage of excess weight lost relative to baseline, calculated to assess long-term weight maintenance following different metabolic bariatric surgeries.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664580, which also lists 3 linked publications.
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 29 Oct 2024.