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)
60
1
2
49.9
1.2

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
  • 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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:
  • AUN
First Posted:
Sep 5, 2021
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Shadad Rateb Mohamed, Assistant lecturer, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2021