Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity
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.
Přehled studie
Postavení
Podmínky
Detailní popis
. 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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Menofyia
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Shibīn al Kawm, Menofyia, Egypt, 11432
- Shebin ElKom Teaching Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Jiný: Control group A
will receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, only.
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conventional balanced, low-calorie diet 1500 k/cal for 12 weeks
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Jiný: Study group B
will receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, plus aerobic training program along 12 weeks.
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conventional balanced, low-calorie diet 1500 k/cal for 12 weeks
aerobic training program along 12 weeks
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Experimentální: study group C
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
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conventional balanced, low-calorie diet 1500 k/cal for 12 weeks
aerobic training program along 12 weeks
extracorporeal shockwave, twice weekly along 12 weeks
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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FIB4
Časové okno: 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.
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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.
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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.
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Hb A1c
Časové okno: 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.
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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.
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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.
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Lipid profile
Časové okno: 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.
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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.
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Waist circumference
Časové okno: 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.
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Assessment tool for addressing abdominal adiposity.
will be discussed for each age era physiological range either for men and women based on worldwide indexing range.
Waist circumference will be measured utilizing standard tape measurement at umbilical level.
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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.
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Waist-Hip Ratio
Časové okno: 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.
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It is an assessing toll for abdominal adiposity utilizing tape measurement tool.
Will assess waist circumference at abdominal level, then the circumference at hip level and divide both values.
The physiological range will be discussed in details at discussion of the study based on both men, and women, and their age era.
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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.
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Skinfold thickness
Časové okno: 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.
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assess of abdominal adiposity, utilizing skinfold caliper (Sequoia Fitness Trimcal 4000, made in USA).
It is based on the assumption that a certain proportion of body fat is located directly beneath the skin.
The normal and physiological values will be measured will be discussed in details at discussion of the study.
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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.
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Body fat percentage
Časové okno: 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.
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assessment of fate adiposity, utilizing In body BODECODER, (made in China) device that permits estimation of body fat percentage.
The values will be measured will be discussed in details at discussion of the study.
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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.
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Lean body mass
Časové okno: 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.
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assessment of abdominal adiposity utilizing In body BODECODER, (made in China) device to estimate lean body mass.
The assessed values will be discussed in details at discussion of the study.
|
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.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Adnan AA Gharib, PHD, GOTHI
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Poruchy výživy
- Nadměrná výživa
- Tělesná hmotnost
- Nadváha
- Obezita
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Obezita, břicho
- Abdominal obesity metabolic syndrome
- Terapeutika
- Modality fyzikální terapie
- Rehabilitace
- Ultrazvuková terapie
- Diatermie
- Hypertermie, indukovaná
- Extrakorporální terapie rázové vlny
Další identifikační čísla studie
- HSH00107
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
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