Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
Primary Purpose
Bariatric Surgery Candidate
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
body contouring
Sponsored by
About this trial
This is an interventional prevention trial for Bariatric Surgery Candidate focused on measuring Bariatric, Weight regain, Metabolism
Eligibility Criteria
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.
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
group A
group B
Arm Description
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
Outcomes
Primary Outcome Measures
weight changes by kilograms
to know the effect of post-bariatric body contouring surgery in weight. Detect the weight cahnges of the patient every month afer body contouring surgery and body mass index also measured every month for six 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
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
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.
Secondary Outcome Measures
Patient satisfaction score
From 1 to 5 .
1 very dissatisfied 5 very satisfied Increase in number means increase satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05034081
Brief Title
Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
Official Title
Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate
Keywords
Bariatric, Weight regain, Metabolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Description
to know the effect of post-bariatric body contouring surgery on weight loss and metabolism
Arm Title
group B
Arm Type
No Intervention
Arm Description
compare this group of patients with group A to detect weight changes and metabolic changes without any post-bariatric intervention
Intervention Type
Procedure
Intervention Name(s)
body contouring
Intervention Description
any post-bariatric body contouring surgery included
Primary Outcome Measure Information:
Title
weight changes by kilograms
Description
to know the effect of post-bariatric body contouring surgery in weight. Detect the weight cahnges of the patient every month afer body contouring surgery and body mass index also measured every month for six months
Time Frame
4 years
Title
Level of Tumor necrotizing factor alfa in blood
Description
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
Time Frame
4 years
Title
Level of BNP in blood
Description
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
Time Frame
4 years
Title
Level of high sensitive CRP in blood
Description
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.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Patient satisfaction score
Description
From 1 to 5 .
1 very dissatisfied 5 very satisfied Increase in number means increase satisfaction.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Shadad, master
Phone
00201020575457
Email
m_shadad@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud abdelaal, MD
Phone
01008996009
Email
Mahmoud.abdel-aal@ucdconnect.ie
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Shadad, Master
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
088
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Rateb, Master
Phone
00201020575457
Email
m_shadad@aun.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared as numbers and the name of participants will not shared
Learn more about this trial
Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism
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