Bariatric Surgery CandidateNCT05034081
Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
A study testing body contouring in people with Bariatric Surgery Candidate, run by Assiut University at 1 site in Egypt.
Trial summary
Is post-bariatric body contouring surgery prevent weight regain or no, and what is the effect on the patient's Metabolism? Few literature studies report body contouring surgery to be positively associated with maintained weight loss after obesity surgery but the measures of outcomes are diverse, and the collective… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- body contouring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post-bariatric (sleeve) patients will do body contouring surgery.
- Post-bariatric patients has been stable within 5 kg for 3 months
- Age between 20-60 years old.
- patients use the determinant fixed diet.
Who cannot join
- Age below 20 and above 60 years old.
- Non-compliance with the fixed diet.
- psychotic patients.
- Female patients seeking pregnancy.
- Endocrine causes of obesity.
- Bariatric surgery other than sleeve.
Trial locations and contacts
1 site in 1 country.
About this study
Is post-bariatric body contouring surgery prevent weight regain or no, and what is the effect on the patient's Metabolism? Few literature studies report body contouring surgery to be positively associated with maintained weight loss after obesity surgery but the measures of outcomes are diverse, and the collective magnitude of such an association is unknown.
The changes in gastrointestinal hormones, adipokines, and cytokines as well as in hypothalamic neuropeptides and neurotransmitters resemble the changes observed in the anorexia/cachexia, suggesting that bariatric surgery triggers a catabolic state responsible for loss of appetite and prolonged body weight reduction.
Weight regain after gastric bypass surgery occurs in about half of all patients within 2 years. About 50% of patients eventually gain a little weight back after hitting their low point. We need a more thorough evaluation to determine what factors - medical, psychological, lifestyle - are involved in the weight gain. One of the factors that seem to be responsible for the degree and durability of weight loss is post-bariatric body contouring procedures. However, metabolic consequences of removing excess subcutaneous adipose tissue by body contouring procedures have to a lesser extent been explored
- Conditions
- Bariatric Surgery Candidate
- Being tested
- body contouring
- Keywords
- Bariatric, Weight regain, Metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body contouringProcedure or surgery
any post-bariatric body contouring surgery included
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | to know the effect of post-bariatric body contouring surgery on weight loss and metabolism Receives: Procedure: body contouring |
| group B | No intervention | compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Changes by Kilograms
to know the effect of post-bariatric body contouring surgery in weight. Detect the weight cahnges of the patient 3 and 6 months after body contouring surgery and body mass index also measured
Measured: 6 months
Level of Tumor Necrotizing Factor Alfa in Blood
Its a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. Tumor necrotizing factor alfa increase afer bariatric surgery and we want to know if its complete on increasing after body contouring surgeries or decresae . Tnf-a is measured by pg/ml
Measured: 6 months
Level of BNP in Blood
Its a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. BNP highly increase with catabolism after bariatric surgery and we want to know the effect of body contouring surgeries in the level of BNP. BNP unit is pg/ml
Measured: 6 months
Level of High Sensitive CRP in Blood
Its a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. hsCRP increase with catabolism after bariatric surgery and we want to know the effect of body contouring surgeries in blood level of hsCRp. The unit of hsCRP is mg/dl.
Measured: 6 months
Secondary outcomes (1)
Patient Satisfaction Score
From 1 to 5 .
1 very dissatisfied 5 very satisfied Increase in number means increase satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Sep 2021
- Primary completion15 Aug 2024
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shadad Rateb Mohamed, Assiut University
- Investigators
- Mohamed Shadad, Master, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034081
- Sponsor's protocol ID
- AUN
- Status last verified
- Apr 2026
- First submitted
- 18 Aug 2021
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared as numbers and the name of participants will not shared
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
- ClinicalTrials.gov ID
- NCT05034081
- Acronym / sponsor ID
- AUN
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric, Weight regain, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is post-bariatric body contouring surgery prevent weight regain or no, and what is the effect on the patient's Metabolism? Few literature studies report body contouring surgery to be positively associated with maintained weight loss after obesity surgery but the measures of outcomes are diverse, and the collective magnitude of such an association is unknown.
The changes in gastrointestinal hormones, adipokines, and cytokines as well as in hypothalamic neuropeptides and neurotransmitters resemble the changes observed in the anorexia/cachexia, suggesting that bariatric surgery triggers a catabolic state responsible for loss of appetite and prolonged body weight reduction.
Weight regain after gastric bypass surgery occurs in about half of all patients within 2 years. About 50% of patients eventually gain a little weight back after hitting their low point. We need a more thorough evaluation to determine what factors - medical, psychological, lifestyle - are involved in the weight gain. One of the factors that seem to be responsible for the degree and durability of weight loss is post-bariatric body contouring procedures. However, metabolic consequences of removing excess subcutaneous adipose tissue by body contouring procedures have to a lesser extent been explored
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: body contouringto know the effect of post-bariatric body contouring surgery on weight loss and metabolism |
| group B | No intervention | –compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Post-bariatric (sleeve) patients will do body contouring surgery.
- Post-bariatric patients has been stable within 5 kg for 3 months
- Age between 20-60 years old.
- patients use the determinant fixed diet.
Key exclusion criteria (6 listed)
- Age below 20 and above 60 years old.
- Non-compliance with the fixed diet.
- psychotic patients.
- Female patients seeking pregnancy.
- Endocrine causes of obesity.
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 |
|---|---|---|
| body contouringany post-bariatric body contouring surgery included | Procedure or surgery | group A |
Primary outcome
Weight Changes by Kilograms
Time frame: 6 months
to know the effect of post-bariatric body contouring surgery in weight. Detect the weight cahnges of the patient 3 and 6 months after body contouring surgery and body mass index also measured
Level of Tumor Necrotizing Factor Alfa in Blood
Time frame: 6 months
Its a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. Tumor necrotizing factor alfa increase afer bariatric surgery and we want to know if its complete on increasing after body contouring surgeries or decresae . Tnf-a is measured by pg/ml
Level of BNP in Blood
Time frame: 6 months
Its a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. BNP highly increase with catabolism after bariatric surgery and we want to know the effect of body contouring surgeries in the level of BNP. BNP unit is pg/ml
Level of High Sensitive CRP in Blood
Time frame: 6 months
Its a clinical laboratory investigation will be done before the body contouring surgeries and 3 and 6 months after. hsCRP increase with catabolism after bariatric surgery and we want to know the effect of body contouring surgeries in blood level of hsCRp. The unit of hsCRP is mg/dl.
1 secondary outcome
Patient Satisfaction Score
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. It will be shared as numbers and the name of participants will not shared
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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.
Mohamed Shadad, Master study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing body contouring in people with Bariatric Surgery Candidate, run by Assiut University at 1 site in Egypt.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Changes by Kilograms (time frame: 6 months). The study lists 4 primary outcomes in all. 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 1 May 2026.