Exercise Training on Brain Insulin Responsiveness

NCT ID: NCT06039787

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Insulin Resistance Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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moderate intensity continuous training

Group Type EXPERIMENTAL

single bout of moderate intensity continuous training (MICT)

Intervention Type BEHAVIORAL

the MICT consists of 60 min continuous cycling

High-intensity interval training

Group Type EXPERIMENTAL

single bout of High Intensity Interval Training (HIIT)

Intervention Type 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 condition

Group Type PLACEBO_COMPARATOR

waiting control

Intervention Type BEHAVIORAL

sitting in a waiting room for 60 min

Interventions

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single bout of moderate intensity continuous training (MICT)

the MICT consists of 60 min continuous cycling

Intervention Type 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

Intervention Type BEHAVIORAL

waiting control

sitting in a waiting room for 60 min

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas L. Birkenfeld, MD

Role: STUDY_DIRECTOR

Institute for Diabetes research and Metabolic Diseases at the University of Tubingen

Locations

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University Clinic Tübingen, Department of Internal Medicine IV

Tübingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stephanie Kullmann, PhD

Role: CONTACT

0049707129 ext. 87703

Facility Contacts

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Stephanie Kullmann, PhD

Role: primary

+49 7071 29 ext. 87703

Other Identifiers

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226/2023BO2

Identifier Type: -

Identifier Source: org_study_id

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