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NCT Number: NCT06039787

Exercise Training on Brain Insulin Responsiveness

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic Tübingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location status: Recruiting

Location contact

Stephanie Kullmann, PhD

CONTACT

[email protected]

+49 7071 29 ext. 87703

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

single bout of moderate intensity continuous training (MICT)

Behavioral

the MICT consists of 60 min continuous cycling

single bout of High Intensity Interval Training (HIIT)

Behavioral

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

waiting control

Behavioral

sitting in a waiting room for 60 min

Primary outcomes

  1. Cerebral response after intranasal insulin administration

    Time frame: 1 hour after exercise or waiting control

    The resting-state cerebral response from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)

Secondary outcomes

  1. Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition

    Time frame: 1 hour after exercise or waiting control

    Food cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)

  2. Subjective feeling of hunger and food craving

    Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control

    Questionnaire assessment before and after exercise or waiting control.

  3. Changes in Blood-brain barrier integrity

    Time frame: 1 hour after exercise or waiting control

    Robust multiple echo-time arterial spin labelling based Blood Brain Barrier integrity measurements from before to after intranasal insulin administration after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)

  4. Performance during cognitive tasks

    Time frame: 1 hour after exercise or waiting control

    Cambridge Cognition Tests Battery to assess memory and inhibitory control using the paired associates learning task, the pattern recognition memory task and the stop-signal reaction task.

  5. Changes in exerkines from plasma samples

    Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control

    Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)

  6. Change in incretins from plasma samples

    Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control

    Blood sampling at 5 time points before and after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Kullmann, PhD

CONTACT

[email protected]

0049707129 ext. 87703

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Effects of One Exercise Training Session on Brain Insulin Responsiveness

Acronym: acEx

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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