The Importance of Insulin Action in the Brain for the Immune System During Physical Activity-Overweight

Обзор

The goal of this clinical trial is to clarify the interaction of central insulin action and physical activity with the immune system. Therefore, participants will undergo bicycle spiroergometer tests. This approach will be compared between days with insulin delivery to the brain as nasal spray and days with placebo spray. In another trial (NCT06552130) lean participants already have been tested. Significant effects on circulating cytokines could be identified. In this amendment, overweight persons in which brain insulin resistance is expected will be tested.

Подробное описание

This research project aims to investigate if the brain insulin action regulates the immune system via the autonomous nervous system during physical activity and investigate whether participants with overweight respond different compared to lean persons. The lean persons were already studied in another trial (NCT06552130) and this trial serves as an amendment.

Insulin action in the brain will be introduced by application of insulin as nasal spray (on one day) versus carrier solution as placebo nasal spray (on another day) in a randomized, blinded fashion. Spray administration will be performed 30 minutes before a 60 min bicycle spiroergometer test at 70 % VO2max that will introduce a postprandial state. On placebo day, the known spillover of tiny amounts of nasal insulin into the systemic circulation will be mimicked by an appropriate i.v. insulin bolus. Using this approach, brain-derived regulation of the immune system including the stimulation of immune cells via cytokines, physical performance, activity of the autonomous nervous system and gene-expression of leukocytes will be examined.

Вмешательства

• Другое Spiroergometer test with intranasal insulin spray
  Participants will undergo a 60 min bicycle spiroergometer test and intranasal insulin spray. Intranasal insulin will be administered 30 minutes prior to the start of the physical activity.
• Другое Spiroergometer test with intranasal placebo spray
  Participants will undergo a 30 min bicycle spiroergometer test and intranasal placebo spray. To mimic insulin spill-over from nasal spray into systemic circulation, an i.v. insulin bolus of 3 mU × kg-1. will be administered over 15 minutes 30 minutes prior to the start of the physical activity on the placebo spray day. On the insulin spray day a comparable amount of saline will be infused.

Первичные конечные точки

• Immune system activation [Срок оценки: 120 minutes]

Вторичные конечные точки (7)

• Maximal oxygen consumption (VO2max) [Срок оценки: 60 minutes]
• Heat rate variability [Срок оценки: 120 minutes]
• Corticotropic pituitary axis modulation [Срок оценки: 120 minutes]
• Leukocyte gene expression [Срок оценки: 120 minutes]
• Individual anaerobic threshold [Срок оценки: 120 minutes]
• Catecholamines [Срок оценки: 120 minutes]
• Effects on blood coagulation parameters [Срок оценки: 120 minutes]

Критерии участия

Критерии включения

• BMI > 28 kg/m2
• no known primary disease
• hormonal contraception with a single-phase preparation

Критерии исключения

• alcohol or drug abuse
• At screening: Hb < 12 g/dl for women and Hb < 14 g/dl for men
• Any (clinical) condition that would endanger participant's safety or question scientific success according to a physician's opinion.

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

• Ulm University Hospital — Ulm

Идентификаторы

NCT: NCT07466173 · 81/24 Amendment

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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