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Идёт набор NCT06973980

HIIT in Sedentary Obese Adults: Effects on Metabolic Risk, Body Composition, and FABP4

Без фазы С лечением High-Intensity Interval Training

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: Exercise.
Кому может быть актуально
Состояния в реестре: High-Intensity Interval Training. Базовые параметры: 20 лет — 35 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
Cyprus
Следующий шаг
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Официальное название

The Effect of High-Intensity Interval Training on Cardiometabolic Risk Factors, Body Composition, and Plasma FABP4 Levels in Sedentary Obese Adults.

Обзор

It is aimed to investigate the responses of Fatty Acid Binding Protein 4 (FABP4), which has been discovered as a novel biomarker of obesity and metabolic diseases, to regular exercise training. The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.

Подробное описание

Fatty acid binding proteins are intracellular proteins involved in the transport of fatty acids and are particularly associated with lipolytic activity. These proteins constitute a group of molecules that regulate intracellular lipid responses and are linked to metabolic and inflammatory pathways.

Studies have shown that FABP4 is associated with hypertension, insulin resistance, obesity, and stroke.

Inhibition of FABP4 synthesis has emerged as a promising strategy for the treatment of obesity-related conditions, particularly insulin resistance and diabetes, and it is emphasized that exercise models to suppress FABP4 should be further investigated.

The aim of this study is to investigate the effects of high-intensity interval training (HIIT) on cardiometabolic risk factors, body composition, and plasma FABP4 levels in sedentary obese adults.

Hypotheses:

H01: HIIT has no effect on cardiometabolic risk factors in sedentary obese adults.

H02: HIIT has no effect on body composition in sedentary obese adults. H03: HIIT has no effect on plasma FABP4 levels in sedentary obese adults.

Вмешательства

  • Другое Exercise
    The exercises will be applied only to the intervention group for 12 weeks and will be progressively intensified every 4 weeks.

Первичные конечные точки

  • Fatty acid-bling protein 4 [Срок оценки: Baseline, week 6 and week 12]
  • Complete Blood Count [Срок оценки: Baseline, week 6 and week 12]
  • Hemoglobin A1c (HbA1c) [Срок оценки: Baseline, week 6 and week 12]
  • Hematocrit (HCT) [Срок оценки: Baseline, week 6 and week 12]
  • Low-Density Lipoprotein [Срок оценки: Baseline, week 6 and week 12]
  • High-Density Lipoprotein [Срок оценки: Baseline, week 6 and week 12]
  • Triglycerides [Срок оценки: Baseline, week 6 and week 12]
  • Fasting Blood Glucose (FBG) [Срок оценки: Baseline, week 6 and week 12]
  • Total Cholesterol [Срок оценки: Baseline, week 6 and week 12]
Вторичные конечные точки (6)
  • Physical Activity Level Assessment [Срок оценки: Baseline, week 6 and week 12]
  • Physical activity level [Срок оценки: Baseline, week 6 and week 12]
  • Assessment of Aerobic Capacity and Exercise Intensity - used to measure an individual's maximal oxygen uptake (VO2max) and determine the intensity of exercise [Срок оценки: Baseline, week 6 and week 12]
  • Anthropometric Measurements [Срок оценки: Baseline, week 6 and week 12]
  • Antropometric Measurement [Срок оценки: Baseline, week 6 and week 12]
  • Antropometric Measurement [Срок оценки: Baseline, week 6 and week 12]

Критерии участия

Критерии включения

  • Aged between 20 and 35 years,
  • BMI between 30 and 35 kg/m²,
  • Waist circumference of 90-100 cm for women, 105-110 cm for men,
  • Sedentary lifestyle (<600 MET-min/week),
  • Referred by a physician (with a statement confirming no contraindication to exercise)."

Критерии исключения

  • BMI > 35,
  • Pregnancy,
  • Cardiovascular Diseases: Individuals with serious cardiovascular issues, such as uncontrolled hypertension, heart failure, coronary artery disease, or a heart attack within the last 6 months, which could pose a risk during exercise.
  • Respiratory Diseases: Individuals with chronic respiratory conditions, such as uncontrolled or severe asthma or COPD, who cannot tolerate exercise due to their condition.
  • Neurological Disorders: Individuals with neurological issues that limit exercise capacity, such as Parkinson's disease, stroke, or multiple sclerosis.
  • Musculoskeletal Issues: Individuals with chronic musculoskeletal problems, particularly knee or hip osteoarthritis, that may increase the risk of pain or injury during exercise.
  • Metabolic or Endocrine Disorders: Individuals with uncontrolled metabolic issues, such as diabetes or thyroid disorders, that could cause blood sugar or hormonal fluctuations during exercise.
  • Acute Infections or Illness: Individuals with acute infections, fever, or recently undergone surgical procedures.
  • Any health condition that may prevent participation in exercise."

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
Открытое
Основная цель
Лечение

Центры проведения

Cyprus · 1 центр
  • Eastern Mediterranean University — Famagusta

Идентификаторы

NCT: NCT06973980 · YDIREL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗