Precision Exercise Therapeutics (PET-pilot)

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718089
• Other study ID #: H-22040452
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: Mathias Ried-Larsen, Ph D
• Phone: +4535457641
• Email: mathias.ried-larsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

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

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS)	Copenhagen	Østerbro

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks
Primary	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	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks
Secondary	24 to 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 24 hours to 48 hours following the exercise bout	6 weeks
Secondary	Variation in insulin sensitivity (Oral glucose sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test	Mean and standard deviations of intra- and inter-individual differences in whole-body insulin sensitivity (Oral glucose sensitivity index) in response to different exercise modalities 1 and 2 days following the previous exercise bout.	6 weeks
Secondary	Variation in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test	Mean and standard deviations of intra- and inter-individual differences in whole-body insulin sensitivity (Matsuda index) in response to different exercise modalities 1 and 2 days following the previous exercise bout.	6 weeks
Secondary	Variation in fasting and postprandial glucose	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) plasma glucose in response to different exercise modalities 1 and 2 days following the previous exercise bout.	6 weeks
Secondary	Variation in fasting and postprandial insulin	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) plasma insulin in response to different exercise modalities 1 and 2 days following the previous exercise bout.	6 weeks
Secondary	Variation in fasting and postprandial plasma C-peptide	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) plasma C-peptide in response to different exercise modalities 1 and 2 days following the previous exercise bout.	6 weeks
Secondary	Variation in fasting and postprandial urinary C-peptide	Mean and standard deviations of intra- and inter-individual differences in fasting and post-prandial (derived from an OGTT) urinary C-peptide in response to different exercise modalities 1 and 2 days following the previous exercise bout.	6 weeks
Secondary	Variation in gastric emptying	Mean and standard deviations of intra- and inter-individual differences in post-prandial (from an OGTT) gastric empyting, measured by paracetamol, in response to different exercise modalities 1 and 2 days following the previous exercise bout.	6 weeks
Secondary	Assessment of free living physical activity	Mean and standard deviations of intra- and inter-individual differences in free living physical activity (measured by accelerometers) in response to different exercise modalities	6 weeks
Secondary	Assessment of continuous glucose	Mean and standard deviations of intra- and inter-individual differences in continuous glucose (measured by continuous glucose monitors) in response to different exercise modalities	6 weeks
Secondary	Assessment of psychosocial stress	Mean and standard deviations of intra- and inter-individual differences in psychosocial stress (measured by questionnaires) in response to different exercise modalities	6 weeks
Secondary	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.	6 weeks