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Clinical Trials/NCT06039787
NCT06039787
Recruiting
Not Applicable

Effects of One Exercise Training Session on Brain Insulin Responsiveness

University Hospital Tuebingen1 site in 1 country40 target enrollmentOctober 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insulin Resistance
Sponsor
University Hospital Tuebingen
Enrollment
40
Locations
1
Primary Endpoint
Cerebral response after intranasal insulin administration
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2023
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition(1 hour after exercise or waiting control)
  • Subjective feeling of hunger and food craving(baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control)
  • Changes in Blood-brain barrier integrity(1 hour after exercise or waiting control)
  • Performance during cognitive tasks(1 hour after exercise or waiting control)
  • Changes in exerkines from plasma samples(baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control)
  • Change in incretins from plasma samples(baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control)

Study Sites (1)

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