Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- FIB4
研究概览
简要总结
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.
详细描述
. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
FIB4
时间窗: 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.
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 A1c
时间窗: 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.
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 profile
时间窗: 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.
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.
次要结局
- 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.)
研究者
Adly A Adam
Physical Therapy Specialist
Cairo University