Precision Exercise Therapeutics (PET-pilot)

NCT05718089 | Completed DMC

• 1 other identifier: H-22040452
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

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

  6 weeks

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

  6 weeks

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

  6 weeks

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

  6 weeks

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

  6 weeks

Study Arms (3)

Continuous aerobic exercise

EXPERIMENTAL

The participants will complete a 10-min warm up, followed by 40 min of continuous aerobic exercise at an individualized intensity at 64-76% of the maximal heart rate HRmax on a bicycle ergometer/walking.

Other: Continuous aerobic exercise

High intensity interval training

EXPERIMENTAL

The training consists of 10 minutes of warm up followed by 25 minutes of high intensity interval training (5 bouts of 4 min at \>85% HRmax interspaced by 4 minutes of low intensity training) and finally a 4 min cool-down.

Other: High intensity interval training

Resistance training

EXPERIMENTAL

The participants will complete moderate intensity whole-body resistance training. This will consist of 4 sets with 4 exercises (leg press, chest press, back row, leg extension in appropriate machines) with a brief warm-up prior to each exercise. Each set will be interspersed by 2-min breaks. Each set (including breaks) will thus equate to 2.5 min. Intensity will be set a 12-repetition max (RM, i.e., can repeated no more than 12 times) or 10 repetitions with 1-2 repetitions in reserve (i.e., 10 repetitions where failure would occur within 1-2 more repetitions).

Other: Resistance training

Interventions

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.

Continuous aerobic exercise

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.

High intensity interval training

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.

Resistance training

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS)

Copenhagen, Østerbro, 2100, Denmark

Location

MeSH Terms

Conditions

Overweight

Interventions

High-Intensity Interval Training; Resistance Training

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Mathias Ried-Larsen, Ph D

  Center for Physical Activity Research, Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly allocated, following successful completion of the baseline measurements. An independent statistician generates a computer-generated randomization schedule including six possible sequence orders using balanced blocks, stratified by sex. The schedule will be forwarded to a secretary not involved in any study procedures and will be stored on a password-protected computer. Sequentially numbered (according to the sequence) opaque, sealed envelopes will be prepared and stored in a locked cabinet in an access restricted room. The envelopes will be lined with aluminum foil to render the envelope impermeable to light. Following the baseline measurements, a study nurse, not involved with any study procedures, will open the envelope, and inform the researcher about the order. The participant be informed about the trial condition upon arrival to lab for the experiments (i.e. on the first morning of each set of trial conditions).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Postdoc

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: February 8, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 30, 2024
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

DK (1)