Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity

NCT07686601 | Enrolling By Invitation DMC

• 1 other identifier: HSH00107
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Obesity; Abdominal Obesity-Metabolic Syndrome; Abdominal Obesity in Young and Middle Aged Adults

Keywords

Abdominal Obesity; Metabolic; Extracorporeal Shock Wave

Outcome Measures

Primary Outcomes (3)

• FIB4

  A tool for fatty liver; a simple, cost-effective, and widely used non-invasive index and nonalcoholic fatty liver disease fibrosis score . It will be based on blood tests via(GEM Premier 3000, Werfen Co., 2020, USA device), and basic demographic data: Age, AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), and Platelet count. Then will utilize that formula: FIB-4 = Age (years)multiplied AST (U/L) divided on Platelet count multiplied by ALT/ 1/2 (U/L).The cutoff values to assess the risk of advanced liver fibrosis or cirrhosis; Score \< 1.30: Low risk of advanced fibrosis. Score 1.30 - 2.67: Indeterminate range. Score \> 2.67: High risk of advanced fibrosis or cirrhosis.

  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

  Accepted as an index of glycemic control tool addressing the insulin resistance assessment tool that measures of glycemia over the prior 3 months. that conducted through laboratory analysis via(GEM Premier 3000, Werfen Co., 2020, USA device). Below 39 mmol/mol: normal, 42-47 mmol/mol: high risk for developing type II diabetes, over 48 mmol/mol: already type II diabetes mellitus.

  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

  as a tool for assessment of Abdominal adiposity. It will be conducted across routine laboratory for assessment of lipid profile including low-density lipoprotein, high-density lipoprotein, triglycerides, those will be discussed in details through discussion chapter. Will utilize laboratory device Sysmex CS-5100 Hemostasis system equipment is manufactured by Siemens manumitted company, Germany.

  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 Outcomes (5)

• Waist circumference

  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

  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

  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

  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

  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.

Study Arms (3)

Control group A

OTHER

will receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, only.

Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks

Study group B

OTHER

will receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, plus aerobic training program along 12 weeks.

Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks; Other: aerobic training program

study group C

EXPERIMENTAL

will receive the conventional balanced, low-calorie diet 1500 k/cal, aerobic training program, plus extracorporeal shockwave (Intellect ESW device, Chattanooga; Falcon hand piece with R15, D20S, and D115 Applicators; V-ACTOR® HF optional 1-31Hz), twice weekly along 12 weeks

Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks; Other: aerobic training program; Other: extracorporeal shockwave therapy

Interventions

conventional balanced, low-calorie diet 1500 k/cal for 12 weeks OTHER

conventional balanced, low-calorie diet 1500 k/cal for 12 weeks

Control group A; Study group B; study group C

aerobic training program OTHER

aerobic training program along 12 weeks

Study group B; study group C

extracorporeal shockwave therapy OTHER

extracorporeal shockwave, twice weekly along 12 weeks

study group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shebin ElKom Teaching Hospital

Shibīn al Kawm, Menofyia, 11432, Egypt

Location

MeSH Terms

Conditions

Obesity, Abdominal; Abdominal obesity metabolic syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Adnan AA Gharib, PHD

  GOTHI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An researcher who will not participate in recruiting, providing intervention, or evaluation will be responsible for randomization,, as well After the initial assessment but before first therapy session, group allocation will be carried out
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy Specialist

Model Details: A prospective, double-blinded, parallel groups, randomized controlled trial

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 7, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)