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Precision Exercise Therapeutics (PET-pilot)

Recruiting
40 - 90 years of age
Both
Phase N/A

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Overview

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.

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

Eligibility

Inclusion Criteria:

  • BMI>25
  • Age> 40 years
  • Inactivity, defined as < 1,5 hours of structured physical activity pr. week at moderate intensity and cycling < 30 minutes/5 km pr. day at moderate intensity (moderate intensity = out of breath but able to speak)

Exclusion Criteria:

  • • HbA1c>53 mmol/mol
    • Uncontrolled hypertension
    • Uncontrolled hyperlipidemia,
    • Known hyperthyroid disease
    • Endocrine disorders causing obesity
    • Known autoimmune disease
    • Unstable cardiovascular disease
    • Glucose lowering medications except for low dose metformin (=<1000 mg/day)
    • Current treatment with anti-inflammatory medication, unless pain killers without prescription
    • No participation in other research intervention studies
    • Pregnancy/considering pregnancy within the study period
    • Conditions countering exercise

Study details

Overweight, Healthy

NCT05718089

Rigshospitalet, Denmark

25 January 2024

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