Exercise Training on Brain Insulin Responsiveness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: single bout of moderate intensity continuous training (MICT), single bout of High Intensity Interval Training (HIIT), waiting control.
- Who it may be relevant to
- Registry conditions: Insulin Resistance, Obesity. Basic parameters: 20 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of One Exercise Training Session on Brain Insulin Responsiveness
Overview
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
- Behavioral single bout of moderate intensity continuous training (MICT)
the MICT consists of 60 min continuous cycling - Behavioral single 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 - Behavioral waiting control
sitting in a waiting room for 60 min
Primary outcome measures
- Cerebral response after intranasal insulin administration [Time frame: 1 hour after exercise or waiting control]
Secondary outcome measures (6)
- 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]
- 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]
- Changes in Blood-brain barrier integrity [Time frame: 1 hour after exercise or waiting control]
- Performance during cognitive tasks [Time frame: 1 hour after exercise or waiting control]
- Changes in exerkines from plasma samples [Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]
- Change in incretins from plasma samples [Time frame: baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- University Clinic Tübingen, Department of Internal Medicine IV — Tübingen
Identifiers
NCT: NCT06039787 · 226/2023BO2