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Идёт набор NCT07359625

Effects of Ketone Bodies on Insulin Sensitivity

Без фазы С лечением Insulin Resistance Obesity & Overweight Energy Metabolism Ketone Body Metabolism

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Простыми словами

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

Что изучают
В протоколе указаны: Growth Hormone, Human, Oral ketone supplement (KetoAid®, KE4), Saline infusion (placebo), Oral placebo drink.
Кому может быть актуально
Состояния в реестре: Insulin Resistance, Obesity & Overweight, Energy Metabolism, Ketone Body Metabolism. Базовые параметры: 55 лет — 70 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
Дания
Следующий шаг
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Официальное название

KETO-SENSE - Effects of Ketone Bodies on Insulin Sensitivity

Обзор

KETO-SENSE is a clinical research study investigating how ketone bodies affect energy metabolism and insulin sensitivity in humans. Ketone bodies are naturally produced by the liver during fasting or prolonged exercise and can serve as an alternative fuel for the brain, heart, and muscles. In this study, ten overweight but otherwise healthy adults aged 55-70 years will participate in four study days at Aarhus University Hospital. Participants will receive one of four interventions in a randomized crossover design: 1) growth hormone (GH) and a ketone supplement, 2) GH and placebo, 3) a saline infusion with the ketone supplement, or 4) placebo (saline infusion and placebo supplement). The study uses advanced PET/CT imaging, indirect calorimetry, and tissue biopsies to measure how ketones influence fat breakdown, glucose uptake, and energy expenditure. By understanding these mechanisms, the study aims to clarify whether oral ketone supplementation can improve insulin sensitivity and energy metabolism - findings that could be relevant for common conditions such as overweight, insulin resistance, and type 2 diabetes.

Вмешательства

  • Препарат Growth Hormone, Human
    Continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) for approximately 7 hours to induce physiological lipolysis.
  • Пищевая добавка Oral ketone supplement (KetoAid®, KE4)
    Oral administration of D-β-hydroxybutyrate ester (R-1,3-butanediol β-hydroxybutyrate).
  • Препарат Saline infusion (placebo)
    Continuous IV infusion of isotonic saline as placebo for growth hormone.
  • Пищевая добавка Oral placebo drink
    Oral administration of an isocaloric placebo drink.

Первичные конечные точки

  • Insulin-stimulated glucose uptake in skeletal muscle and organs measured by [¹⁸F]-FDG PET [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Tissue-specific uptake of β-hydroxybutyrate and palmitate measured by PET/CT imaging [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Tissue-specific oxidation of β-hydroxybutyrate and palmitate measured by PET/CT imaging [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Energy expenditure [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Cardiac output measured by PET/CT imaging [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Myocardial glucose and fatty acid uptake rates [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
Вторичные конечные точки (9)
  • Skeletal muscle pyruvate dehydrogenase (PDHa) enzymatic activity [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Adipose tissue lipoprotein lipase (LPL) enzymatic activity [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Expression levels of lipolytic regulatory proteins in adipose tissue [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Phosphorylation levels of insulin-regulated proteins in skeletal muscle [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Expression levels of insulin-regulated proteins in skeletal muscle [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Expression levels of GH-regulated proteins (GHR, JAK2, STAT5, BCL6) in skeletal muscle and adipose tissue [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Relative mRNA expression of GH-responsive genes (SOCS1-3, CISH, IGF-I) in skeletal muscle and adipose tissue [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Skeletal muscle mitochondrial oxidative phosphorylation capacity [Срок оценки: During four experimental study days conducted over approximately 12 weeks]
  • Muscle glycogen content [Срок оценки: During four experimental study days conducted over approximately 12 weeks]

Критерии участия

Критерии включения

  • Age range: 55-70 yr
  • BMI: 25 - 35 kg/m2

Критерии исключения

\- Any evidence of acute or chronic illnesses, apart from well-controlled hypertension, that is judged by the investigators to impact the study

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

Дания · 1 центр
  • Aarhus University Hospital — Aarhus N

Идентификаторы

NCT: NCT07359625 · KETO-SENSE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗