- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05034081
Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypt, 088
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group A
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
|
any post-bariatric body contouring surgery included
|
|
No Intervention: group B
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
|
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
|
6 months
|
|
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
|
6 months
|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Satisfaction Score
Time Frame: 6 months
|
From 1 to 5 . 1 very dissatisfied 5 very satisfied Increase in number means increase satisfaction. |
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed Shadad, Master, Assiut University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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