Clinical trial

Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity

Invitation only · Not applicable · 1 countries · Registry ID NCT07686601

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionAbdominal Obesity, Abdominal Obesity-Metabolic Syndrome, Abdominal Obesity in Young and Middle Aged Adults

Full registry criteria

Inclusion criteria: This study will be delimited by: 1. Age \> 18years old. 2. All of them suffered from abdominal obesity. 3. 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: 1. Patients with diabetes mellitus, heart and/ or vascular, renal, hepatic, pulmonary, neurological, psychological, and or mental disorders are excluded. 2. Patients who had autoimmune diseases were excluded. 3. Patients with hypertension, metal or electronic implants were excluded. 4. Patients, who have intra-abdominal mesh and/ or unrepaired abdominal hernia were excluded. 5. Patients who have cancer were excluded. 6. Patients who have scars, open lesions and wounds at treatment area were excluded. 7. Patients who have any intervention to lose weight or body contouring within the last 6 months (diet, exercise or body contouring devices) were excluded. 8. Patients who received pharmacological drugs for controlling obesity were excluded.

Treatments and study arms

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

Other

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

aerobic training program

Other

aerobic training program along 12 weeks

extracorporeal shockwave therapy

Other

extracorporeal shockwave, twice weekly along 12 weeks

Primary outcomes

FIB41. 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.

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.

Hb A1c1. 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.

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.

Lipid profile1. 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.

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Shebin ElKom Teaching Hospital🇪🇬 Shibīn al Kawm, Menofyia, Egypt

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