Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, aerobic training program, extracorporeal shockwave therapy.
- Who it may be relevant to
- Registry conditions: Abdominal Obesity, Abdominal Obesity-Metabolic Syndrome, Abdominal Obesity in Young and Middle Aged Adults. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Egyptian Ministry of Health and Population's Preventive Sector, have named obesity as one of the top contributors to the national mortality and morbidity. Abdominal obesity is a strong predictor of metabolic disorders and premature mortality. Visceral fat is metabolically active and sensitive for lipolysis, unless it is more insulin resistant. It is well-known that overweight and/ or obesity is associated with overactivated proinflammatory cytokines those overactivated inflammatory process thus led to organs dysfunction across persistent low-grade inflammations . Recently, extracorporeal shock wave represents a promising, non-invasive management strategy supporting the treatment of a variety of conditions related to plastic surgery. As well, it displayed a good safety profile with no serious adverse events . The need of this study develops from the lack in the quantitative knowledge and information regarding overall metabolic effectiveness of the Extracorporeal Shockwave on abdominal adiposity.
Detailed description
. Egyptian Ministry of Health and Population's Preventive Sector, have named obesity as one of the top contributors to the national mortality and morbidity of Egyptians along with other non-communicable disease (NCDs). Chronic NCDs cause 41% of all mortality in Egypt .Abdominal obesity is a strong predictor of metabolic disorders and premature mortality. Visceral fat is metabolically active and sensitive for lipolysis, unless it is more insulin resistant. It is well-known that overweight and/ or obesity is associated with overactivated proinflammatory cytokines those overactivated inflammatory process thus led to organs dysfunction across persistent low-grade inflammations . Recently, extracorporeal shock wave represents a promising, non-invasive management strategy supporting the treatment of a variety of conditions related to plastic surgery. As well, it displayed a good safety profile with no serious adverse events .
The need of this study develops from the lack in the quantitative knowledge and information regarding overall metabolic effectiveness of the Extracorporeal Shockwave on abdominal adiposity.
A prospective, double-blinded, parallel groups, randomized controlled trial.Ninety participants, \> 18years old, whom had abdominal obesity, were randomly allocated either into the study groups, and the control group. They will be recruited from The Out-patient Clinics of Shebin ElKom teaching Hospital, Menofyia, Egypt.The control group A received the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, only. While, study group B received the conventional balanced, low-calorie diet 1500 k/cal, plus aerobic training program along 12 weeks, and study group C received the conventional balanced, low-calorie diet 1500 k/cal, aerobic training program, plus extracorporeal shockwave, twice weekly along 12 weeks. By the end of the interventional protocol, each participant will be checked twice along 12 months for follow-up. FIB4 as a tool for fatty liver, Hb A1c and lipid profile measures via laboratory analysis, Body mass index (BMI), waist circumference (WC), waist/hip ratio (WHR), and skinfold thickness, and body fat percentage, and lean body mass via bioelectrical impedance analysis will be measured at baseline, after 12 weeks of interventions, and every 6 months for follow-up.
Interventions
- Other conventional balanced, low-calorie diet 1500 k/cal for 12 weeks
conventional balanced, low-calorie diet 1500 k/cal for 12 weeks - Other aerobic training program
aerobic training program along 12 weeks - Other extracorporeal shockwave therapy
extracorporeal shockwave, twice weekly along 12 weeks
Primary outcome measures
- FIB4 [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
- Hb A1c [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
- Lipid profile [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
Secondary outcome measures (5)
- Waist circumference [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
- Waist-Hip Ratio [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
- Skinfold thickness [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
- Body fat percentage [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
- Lean body mass [Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.]
Eligibility criteria
Inclusion criteria
This study will be delimited by:
- Age > 18years old.
- All of them suffered from abdominal obesity.
- All have waist/ hip ratio of > 0.85 and their waist circumference > 90 cm.
Exclusion criteria
Patients who had the following features will be excluded from the study:
- Patients with diabetes mellitus, heart and/ or vascular, renal, hepatic, pulmonary, neurological, psychological, and or mental disorders are excluded.
- Patients who had autoimmune diseases were excluded.
- Patients with hypertension, metal or electronic implants were excluded.
- Patients, who have intra-abdominal mesh and/ or unrepaired abdominal hernia were excluded.
- Patients who have cancer were excluded.
- Patients who have scars, open lesions and wounds at treatment area were excluded.
- Patients who have any intervention to lose weight or body contouring within the last 6 months (diet, exercise or body contouring devices) were excluded.
- Patients who received pharmacological drugs for controlling obesity were excluded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Shebin ElKom Teaching Hospital — Shibīn al Kawm
Identifiers
NCT: NCT07686601 · HSH00107