Exercise Training on Brain Insulin Responsiveness

Официальное название

Effects of One Exercise Training Session on Brain Insulin Responsiveness

Обзор

The overarching goal of the current study is to investigate the effect of one acute bout of exercise on the brain insulin responsiveness in a cross-over study design. To this end, investigators will compare the effect of two single endurance exercise sessions with different intensities, namely moderate intensity continuous training (MICT) and high-intensity-interval-training (HIIT), which will be performed in a randomized order. This will be compared to a waiting control condition.

Подробное описание

Investigate one acute bout of exercise on the brain insulin responsiveness using functional magnetic resonance imaging in combination with intranasal insulin in healthy participants of normal-weight and overweight/obesity. Two single endurance exercise sessions with different intensities will be evaluated, namely moderate intensity continuous training (MICT) and high-intensity interval training (HIIT). This will be compared to a waiting control condition. In a cross-over design, investigators will compare cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT compared to a control condition without exercise. Cerebral response is defined as the cerebral blood flow and resting state functional connectivity in response to intranasal insulin. Secondary outcomes include changes in blood metabolites and proteins and changes in eating behavior.

Вмешательства

• Поведенческое single bout of moderate intensity continuous training (MICT)
  the MICT consists of 60 min continuous cycling
• Поведенческое single bout of High Intensity Interval Training (HIIT)
  HIIT consists of 10-min warm-up at the power output corresponding to 50% peak power output (PPO), 4 x 4-min intervals at a power output corresponding to 75% PPO with a 4-min active resting period at 30% PPO to recover
• Поведенческое waiting control
  sitting in a waiting room for 60 min

Первичные конечные точки

• Cerebral response after intranasal insulin administration [Срок оценки: 1 hour after exercise or waiting control]

Вторичные конечные точки (6)

• Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition [Срок оценки: 1 hour after exercise or waiting control]
• Subjective feeling of hunger and food craving [Срок оценки: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]
• Changes in Blood-brain barrier integrity [Срок оценки: 1 hour after exercise or waiting control]
• Performance during cognitive tasks [Срок оценки: 1 hour after exercise or waiting control]
• Changes in exerkines from plasma samples [Срок оценки: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]
• Change in incretins from plasma samples [Срок оценки: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]

Критерии участия

Критерии включения

• BMI between ≥ 19.5 to 39 kg/m2-
• Less than 150 min/week for moderate-intensity physical activity
• Less than 75 min/week for Vigorous- intensity exercise (WHO recommendations for regular physical activity of adults)
• Written consent to participate in the study
• Written consent to be informed about incidental findings

Критерии исключения

• Type 2 diabetes, cardiovascular diseases such as chronic heart failure, myocardial infarction, status post stroke
• Limitations to participate in ergometer-based exercise (balance and coordination disorders, orthopedic problems, …)
• Insufficient knowledge of the German language
• Persons who cannot legally give consent
• Pregnancy or lactation
• History of severe mental or somatic disorders including neurological diseases (incl. epileptic seizures and migraines)
• Taking psychotropic drugs
• Taking medications that influence glucose metabolism
• Regular use of analgesic drugs
• Taking anticoagulant agents
• Previous bariatric surgery
• Acute infection within the last 4 weeks
• Hemoglobin values less than 12g/dl for women, less than 14 g/dl for men
• Other diseases that in the opinion of the investigator may jeopardize the success of the study or indicate a risk to the volunteer
• Current participation in a lifestyle intervention study or a pharmaceutical study
• Metal implants which cannot be removed as pacemakers, artificial heart valve, electrical devices as insulin pumps, large tattoos, retainer over more than 4 teeth, contraceptive coil, implanted magnetic metal parts as screws or plates after a surgery
• Persons with claustrophobia
• Temperature-sensitive person
• Persons with tinnitus or increased sensitivity to loud sounds

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Германия · 1 центр

• University Clinic Tübingen, Department of Internal Medicine IV — Tübingen

Идентификаторы

NCT: NCT06039787 · 226/2023BO2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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