Clinical trial NCT06039787: Exercise Training on Brain Insulin Responsiveness
Official title: Effects of One Exercise Training Session on Brain Insulin Responsiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Resistance
Obesity
Keywords: Exercise
functional magnetic resonance imaging
Intranasal insulin
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In a cross-over design, we 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.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria

* 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

Primary outcomes:
measure: Cerebral response after intranasal insulin administration
timeFrame: 1 hour after exercise or waiting control
Secondary outcomes:
measure: Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition
timeFrame: 1 hour after exercise or waiting control
measure: Subjective feeling of hunger and food craving
timeFrame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
measure: Changes in Blood-brain barrier integrity
timeFrame: 1 hour after exercise or waiting control
measure: Performance during cognitive tasks
timeFrame: 1 hour after exercise or waiting control
measure: Changes in exerkines from plasma samples
timeFrame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
measure: Change in incretins from plasma samples
timeFrame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Clinic Tübingen, Department of Internal Medicine IV
Study officials:
affiliation: Institute for Diabetes research and Metabolic Diseases at the University of Tubingen
name: Andreas L. Birkenfeld, MD
role: STUDY_DIRECTOR
References: