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Completed

NCT Number: NCT05718089

Precision Exercise Therapeutics (PET-pilot)

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.

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Key information

Conditions

Overweight Body Weight Healthy Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS)

Copenhagen, Østerbro, 2100, Denmark

About this study

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

  • to assess the longevity of the increased whole-body insulin sensitivity in the days following different exercise modalities
  • To estimate the intra-individual differences of different exercise modalities on whole-body insulin sensitivity the days following the last exercise bout
  • To assess the fidelity of the test- and exercise protocols

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Aerobic Exercise

Other

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.

High Intensity Interval Training

Other

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.

Resistance training

Other

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.

Primary outcomes

  1. 24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 24 hours following the exercise bout

Secondary outcomes

  1. 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose sensitivity index) from baseline to 48 hours following the exercise bout

  2. 24 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose insulin sensitivity index) from baseline to 24 hours following the exercise bout

  3. 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 48 hours following the exercise bout

  4. 24 to 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    Difference between exercise modalities in the change in whole-body insulin sensitivity (Oral glucose sensitivity index) from 24 hours to 48 hours following the exercise bout

  5. 24 to 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from 24 hours to 48 hours following the exercise bout

  6. Variation in insulin sensitivity (Oral glucose sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in whole-body insulin sensitivity (Oral glucose sensitivity index) in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in whole-body insulin sensitivity (Oral glucose sensitivity index) in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).

  7. Variation in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in whole-body insulin sensitivity (Matsuda index) in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in whole-body insulin sensitivity (Matsuda index) in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).

  8. Variation in fasting and postprandial glucose

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in fasting and post-prandial (derived from an OGTT) plasma glucose in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in fasting and post-prandial (derived from an OGTT) plasma glucose in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).

  9. Variation in fasting and postprandial insulin

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in fasting and post-prandial (derived from an OGTT) plasma insulin in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in fasting and post-prandial (derived from an OGTT) plasma insulin in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).

  10. Variation in fasting and postprandial plasma C-peptide

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in fasting and post-prandial (derived from an OGTT) plasma C-peptide in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in fasting and post-prandial (derived from an OGTT) plasma C-peptide in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).

  11. Variation in gastric emptying

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in post-prandial (from an OGTT) gastric empyting, measured by paracetamol, in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in post-prandial (from an OGTT) gastric empyting, measured by paracetamol, in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).

  12. Assessment of free living physical activity

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in free living physical activity (measured by accelerometers) in response to different exercise modalities 1 day following the previous exercise bout (intra-individual variation) and inter-individual response variability in free living physical activity (measured by accelerometers) in response to different exercise modalities 1 day following the previous exercise bout (inter-individual variation).

  13. Assessment of continuous glucose

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in continuous glucose (measured by continuous glucose monitors) in response to different exercise modalities following the previous exercise bout (intra-individual variation) and inter-individual response variability in continuous glucose (measured by continuous glucose monitors) in response to different exercise modalities following the previous exercise bout (inter-individual variation).

  14. Assessment of psychosocial stress

    Time frame: 6 weeks

    The typical difference between a pair of replicate measurements in psychosocial stress (measured by questionnaires) in response to different exercise modalities following the previous exercise bout (intra-individual variation) and inter-individual response variability in psychosocial stress (measured by questionnaires) in response to different exercise modalities following the previous exercise bout (inter-individual variation).

  15. Feasibility of the test and training protocols

    Time frame: 6 weeks

    Feasibility will be assessed using a qualitative questionnaires. Subject domains include e.g. participant satisfaction with 1) time spend on test- and training, 2) the recruitment process, 3) communication regarding participation and 4) the written information about participation, 5) acceptability of the tests.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 8, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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