Back to resultsExercise Training on Brain Insulin Responsiveness (acEx)
Primary Purpose
Insulin Resistance, Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
single bout of moderate intensity continuous training (MICT)
single bout of High Intensity Interval Training (HIIT)
waiting control
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance focused on measuring Exercise, functional magnetic resonance imaging, Intranasal insulin
Eligibility Criteria
Inclusion Criteria: Normal weight group: BMI between ≥ 19.5 to 24.5 kg/m2 Overweight/Obesity group: BMI between ≥ 27.5 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
Sites / Locations
- University Clinic Tübingen, Department of Internal Medicine IV
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
moderate intensity continuous training
High-intensity interval training
Waiting condition
Arm Description
Outcomes
Primary Outcome Measures
Cerebral response after intranasal insulin administration
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 Outcome Measures
Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition
Food cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Subjective feeling of hunger and food craving
Questionnaire assessment before and after exercise or waiting control.
Changes in Blood-brain barrier integrity
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)
Performance during cognitive tasks
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.
Changes in exerkines from plasma samples
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)
Change in incretins from plasma samples
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)
Full Information
NCT ID
NCT06039787
First Posted
September 6, 2023
Last Updated
September 13, 2023
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT06039787
Brief Title
Exercise Training on Brain Insulin Responsiveness
Acronym
acEx
Official Title
Effects of One Exercise Training Session on Brain Insulin Responsiveness
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Obesity
Keywords
Exercise, functional magnetic resonance imaging, Intranasal insulin
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
moderate intensity continuous training
Arm Type
Experimental
Arm Title
High-intensity interval training
Arm Type
Experimental
Arm Title
Waiting condition
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
single bout of moderate intensity continuous training (MICT)
Intervention Description
the MICT consists of 60 min continuous cycling
Intervention Type
Behavioral
Intervention Name(s)
single bout of High Intensity Interval Training (HIIT)
Intervention Description
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
Intervention Name(s)
waiting control
Intervention Description
sitting in a waiting room for 60 min
Primary Outcome Measure Information:
Title
Cerebral response after intranasal insulin administration
Description
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)
Time Frame
1 hour after exercise or waiting control
Secondary Outcome Measure Information:
Title
Task based brain activation after high-intensity-interval-training (HITT) or moderate intensity continuous training (MICT) compared to control condition
Description
Food cue reactivity after a single bout of HIIT or MICT exercise compared to a control condition without exercise (i.e., waiting control)
Time Frame
1 hour after exercise or waiting control
Title
Subjective feeling of hunger and food craving
Description
Questionnaire assessment before and after exercise or waiting control.
Time Frame
baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Title
Changes in Blood-brain barrier integrity
Description
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)
Time Frame
1 hour after exercise or waiting control
Title
Performance during cognitive tasks
Description
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.
Time Frame
1 hour after exercise or waiting control
Title
Changes in exerkines from plasma samples
Description
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)
Time Frame
baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
Title
Change in incretins from plasma samples
Description
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)
Time Frame
baseline, 1 hour after breakfast, 1 hour, 2 hour, 3 hours after exercise or waiting control
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal weight group: BMI between ≥ 19.5 to 24.5 kg/m2
Overweight/Obesity group: BMI between ≥ 27.5 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Kullmann, PhD
Phone
0049707129
Ext
87703
Email
stephanie.kullmann@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas L. Birkenfeld, MD
Organizational Affiliation
Institute for Diabetes research and Metabolic Diseases at the University of Tubingen
Official's Role
Study Director
Facility Information:
Facility Name
University Clinic Tübingen, Department of Internal Medicine IV
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Exercise Training on Brain Insulin Responsiveness
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