NCT05034081

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 1, 2026

Completed
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

August 18, 2021

Results QC Date

March 5, 2026

Last Update Submit

April 11, 2026

Conditions

Keywords

BariatricWeight regainMetabolism

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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.

    6 months

Secondary Outcomes (1)

  • Patient Satisfaction Score

    6 months

Study Arms (2)

group A

EXPERIMENTAL

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

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

Interventions

any post-bariatric body contouring surgery included

group A

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Asyut Governorate, 088, Egypt

Location

MeSH Terms

Interventions

Body Contouring

Intervention Hierarchy (Ancestors)

Cosmetic TechniquesTherapeuticsPlastic Surgery ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
MOHAMED Shadad rateb
Organization
AssiutU

Study Officials

  • Mohamed Shadad, Master

    Assiut University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 18, 2021

First Posted

September 5, 2021

Study Start

September 1, 2021

Primary Completion

August 15, 2024

Study Completion

August 15, 2025

Last Updated

May 1, 2026

Results First Posted

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

It will be shared as numbers and the name of participants will not shared

Locations