Exercise Training on Brain Insulin Responsiveness

NCT06039787 | Recruiting

• 1 other identifier: 226/2023BO2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Obesity

Keywords

Exercise; functional magnetic resonance imaging; Intranasal insulin

Outcome Measures

Primary Outcomes (1)

• 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)

  1 hour after exercise or waiting control

Secondary Outcomes (6)

• 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

Study Arms (3)

moderate intensity continuous training

EXPERIMENTAL

Behavioral: single bout of moderate intensity continuous training (MICT)

High-intensity interval training

EXPERIMENTAL

Behavioral: single bout of High Intensity Interval Training (HIIT)

Waiting condition

PLACEBO COMPARATOR

Behavioral: waiting control

Interventions

single bout of moderate intensity continuous training (MICT) BEHAVIORAL

the MICT consists of 60 min continuous cycling

moderate intensity continuous training

single bout of High Intensity Interval Training (HIIT) 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

High-intensity interval training

waiting control BEHAVIORAL

sitting in a waiting room for 60 min

Waiting condition

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Clinic Tübingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Andreas L. Birkenfeld, MD

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

  STUDY DIRECTOR

Central Study Contacts

Stephanie Kullmann, PhD

CONTACT

0049707129; stephanie.kullmann@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 15, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 8, 2023

Record last verified: 2023-09

Locations

DE (1)