NCT05718089

Precision Exercise Therapeutics (PET-pilot)

Individual Responses in Insulin Sensitivity to Different Exercise Modalities in Persons With Overweight: a Randomized Cross-over Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Accepted

Summary

The aim of this randomized cross-over study is to collect information for the design of a precision exercise therapy cohort that will predict what modality of physical activity a physically inactive individual with overweight should perform to increase insulin sensitivity given their unique biology, environment, and context.

Detailed description

This pilot study is needed prior to launching precision therapeutics programs, with the purpose to decrease the risk of research waste, increase the reliability of the experimental tests and estimate adequate sample size. 25 participants will be recruited to undergo three sets of experiments. An experiment consists of one exercise bout followed by an assessment of whole-body insulin sensitivity (measured from a oral glucose tolerance test) 1 and 2 days following the completion of the exercise bout yielding 19 study days of 3 hours each across 7 weeks, including the baseline measurement. The exercise modalities include 1) continuous aerobic exercise, 2) high intensity exercise and 3) resistance exercise training. A set consists of test-retest of the same experiment. The objectives of this pilot study are 1. to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities 2. To estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout 3. To assess the fidelity of the test- and exercise protocols

Conditions

• Overweight
• Healthy

Interventions

Type	Name	Description
OTHER	Continuous aerobic exercise	The "Continuous aerobic exercise" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The " Continuous aerobic exercise" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session. An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.
OTHER	High intensity interval training	The "High intensity interval training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "High intensity interval training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session. An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.
OTHER	Resistance training	The "Resistance training" session will be performed in total two times, as it will be repeated in sets on consecutive weeks (e.g. Two Tuesdays in a row) with a 1-week wash-out period. The "Resistance training" intervention is matched to the other arms on the time spend for each bout equating a total of 50 minutes of exercise per session. An oral glucose tolerance test will be performed 24 hours and 48 hours after the exercise bout.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-31
• Completion: 2024-07-30
• First posted: 2023-02-08
• Last updated: 2025-07-22

Locations

1 site across 1 country: Denmark