Clinical trial NCT05718089: Precision Exercise Therapeutics (PET-pilot)
Official title: Individual Responses in Insulin Sensitivity to Different Exercise Modalities in Persons With Overweight: a Randomized Cross-over Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Healthy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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 criteria: 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

Primary outcomes:
measure: 24 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: 24 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
Secondary outcomes:
measure: 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: 24 to 48 hour change in insulin sensitivity (Oral glucose insulin sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: 24 to 48 hour change in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: Variation in insulin sensitivity (Oral glucose sensitivity index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: Variation in insulin sensitivity (Matsuda index) derived from a 2-hour Oral Glucose Tolerance Test
timeFrame: 6 weeks
measure: Variation in fasting and postprandial glucose
timeFrame: 6 weeks
measure: Variation in fasting and postprandial insulin
timeFrame: 6 weeks
measure: Variation in fasting and postprandial plasma C-peptide
timeFrame: 6 weeks
measure: Variation in fasting and postprandial urinary C-peptide
timeFrame: 6 weeks
measure: Variation in gastric emptying
timeFrame: 6 weeks
measure: Assessment of free living physical activity
timeFrame: 6 weeks
measure: Assessment of continuous glucose
timeFrame: 6 weeks
measure: Assessment of psychosocial stress
timeFrame: 6 weeks
measure: Feasibility of the test and training protocols
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Center for Aktiv Sundhed - Rigshospitalet, Denmark (CFAS)
state: Østerbro
Study officials:
affiliation: Center for Physical Activity Research, Rigshospitalet
name: Mathias Ried-Larsen, Ph D
role: PRINCIPAL_INVESTIGATOR
References: