Меню
Набор по приглашению NCT07686601

Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity

Без фазы С лечением Abdominal Obesity Abdominal Obesity-Metabolic Syndrome Abdominal Obesity in Young and Middle Aged Adults

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, aerobic training program, extracorporeal shockwave therapy.
Кому может быть актуально
Состояния в реестре: Abdominal Obesity, Abdominal Obesity-Metabolic Syndrome, Abdominal Obesity in Young and Middle Aged Adults. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

. 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.

Вмешательства

  • Другое conventional balanced, low-calorie diet 1500 k/cal for 12 weeks
    conventional balanced, low-calorie diet 1500 k/cal for 12 weeks
  • Другое aerobic training program
    aerobic training program along 12 weeks
  • Другое extracorporeal shockwave therapy
    extracorporeal shockwave, twice weekly along 12 weeks

Первичные конечные точки

  • FIB4 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]
Вторичные конечные точки (5)
  • Waist circumference [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Shebin ElKom Teaching Hospital — Shibīn al Kawm

Идентификаторы

NCT: NCT07686601 · HSH00107

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗