Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism

Bariatric Surgery Candidate Clinical Trial

Official title:

Impact Of Post-Bariatric Body Contouring Procedures on Patient Body Weight and Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05034081
• Other study ID #: AUN
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 30, 2025

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: Mohamed Shadad, master
• Phone: 00201020575457
• Email: m_shadad[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Body Weight

Intervention

Procedure:
• body contouring
any post-bariatric body contouring surgery included

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 years
Primary	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	4 years
Primary	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	4 years
Primary	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.	4 years
Secondary	Patient satisfaction score	From 1 to 5 .; 1 very dissatisfied 5 very satisfied Increase in number means increase satisfaction.	4 years