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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
24
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.
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.
Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS)
Copenhagen, Østerbro, Denmark
24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 24 hours following the exercise bout
Time frame: 6 weeks
48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
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
Time frame: 6 weeks
24 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
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
Time frame: 6 weeks
48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from baseline to 48 hours following the exercise bout
Time frame: 6 weeks
24 to 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
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
Time frame: 6 weeks
24 to 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
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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.
Difference between exercise modalities in the change in whole-body insulin sensitivity (Matsuda index) from 24 hours to 48 hours following the exercise bout
Time frame: 6 weeks
Variation in insulin sensitivity (Oral glucose sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
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).
Time frame: 6 weeks
Variation in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
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).
Time frame: 6 weeks
Variation in fasting and postprandial glucose
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).
Time frame: 6 weeks
Variation in fasting and postprandial insulin
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).
Time frame: 6 weeks
Variation in fasting and postprandial plasma C-peptide
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).
Time frame: 6 weeks
Variation in gastric emptying
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).
Time frame: 6 weeks
Assessment of free living physical activity
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).
Time frame: 6 weeks
Assessment of continuous glucose
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).
Time frame: 6 weeks
Assessment of psychosocial stress
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).
Time frame: 6 weeks
Feasibility of the test and training protocols
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.
Time frame: 6 weeks