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

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05034081

Collaborator

(none)

Enrollment

Location

Arms

49.9

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Bariatric Surgery Candidate	Procedure: body contouring	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2025

Anticipated Study Completion Date :

Oct 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A to know the effect of post-bariatric body contouring surgery on weight loss and metabolism	Procedure: body contouring 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

Arm

Intervention/Treatment

Experimental: group A

to know the effect of post-bariatric body contouring surgery on weight loss and metabolism

Procedure: body contouring

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

Outcome Measures

Primary Outcome Measures

weight changes by kilograms [4 years]
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 [4 years]
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 [4 years]
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 [4 years]
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 [4 years]
From 1 to 5 . 1 very dissatisfied 5 very satisfied Increase in number means increase satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt	088

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Mohamed Shadad, Master, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Shadad Rateb Mohamed, Assistant lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT05034081

Other Study ID Numbers:

First Posted:

Sep 5, 2021

Last Update Posted:

Sep 9, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed Shadad Rateb Mohamed, Assistant lecturer, Assiut University

Bariatric

Weight regain

Metabolism

Additional relevant MeSH terms:

Body Weight

Study Results

No Results Posted as of Sep 9, 2021