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Exercise Training on Brain Insulin Responsiveness

Effects of One Exercise Training Session on Brain Insulin Responsiveness

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06039787
Acronym
acEx
Enrollment
40
Registered
2023-09-15
Start date
2023-10-20
Completion date
2026-12-31
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance, Obesity

Keywords

Exercise, functional magnetic resonance imaging, Intranasal insulin

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.

Interventions

BEHAVIORALsingle bout of moderate intensity continuous training (MICT)

the MICT consists of 60 min continuous cycling

BEHAVIORALsingle 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

BEHAVIORALwaiting control

sitting in a waiting room for 60 min

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral response after intranasal insulin administration1 hour after exercise or waiting controlThe 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

MeasureTime frameDescription
Subjective feeling of hunger and food cravingbaseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting controlQuestionnaire assessment before and after exercise or waiting control.
Changes in Blood-brain barrier integrity1 hour after exercise or waiting controlRobust 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)
Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition1 hour after exercise or waiting controlFood cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Changes in exerkines from plasma samplesbaseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting controlBlood 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)
Change in incretins from plasma samplesbaseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting controlBlood 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)
Performance during cognitive tasks1 hour after exercise or waiting controlCambridge 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.

Countries

Germany

Contacts

Primary ContactStephanie Kullmann, PhD
stephanie.kullmann@med.uni-tuebingen.de0049707129

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026