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The Effect of 12-week Circuit Training on Insulin Sensitivity and Endothelial Function in Women With Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528693
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
Poznan University of Medical Sciences
Information provided by (Responsible Party):
Marzena Ratajczak, Poznan University of Physical Education

Brief Summary:

During the last 10 years many studies concerning the impact of physical training on whole-body insulin sensitivity have been published, but there is a lack of an extended investigation on the potential clinical benefits of novel circuit training-based on strength and endurance exercises-relating to the optimization of insulin sensitivity and vascular endothelial function. It is of interest to precisely determine the physiological and biochemical effects of circuit training. An important aspect of the planned research will be the analysis of the effects of physical training on the released during muscle contraction myokines capable of modulating various metabolic processes. We hypothesized that in studied participants 12 weeks of the novel form of training would result in improving insulin sensitivity and vascular endothelial function mainly via myokines released by contracting skeletal muscles.

The following questions will be asked: (1) whether the 12-week circuit training (combined strength and endurance exercises) performed by women with insulin resistance, improves insulin sensitivity, carbohydrate and lipid metabolism and promotes the efficiency of endothelial defense mechanisms? (2) whether the 12-week circuit training (combined of strength and endurance exercises) changes the concentrations of transcription factors regulating lipid and carbohydrate metabolism or the synthesis and/or secretion of myokines and adipokines in women with insulin resistance? (3) whether the 12-week strength training, interspersed with bouts of endurance exercise has a positive effect on cytokine profile? (4) whether there is a relationship between changes in body composition, HOMA-IR, and the level of myokines caused by physical training? (5) whether the 12-week circuit training reduces low back pain symptoms, plantar stifness and improve functioning of the patient in everyday life? A group of 80 women, aged 25 to 45 years, with diagnosed insulin resistance will participate in the planned study. Participants will be enrolled in the research program based on medical qualification. Before the intervention all women will have venous blood collected to determine fasting glucose, hemoglobin glycosylated (HbA1C) and insulin levels and insulin resistance by the homeostasis model assessment of insulin resistance (HOMA-IR) will be calculated. The inclusion criteria will be as follows: (1) women, age: 25-45 years, menstruating, (2) BMI 18,5-29,9 kg/m2, (3) insulin resistance based on HOMA-IR (cut-off point 2.5), (4) HbA1C ≤ 6.5%, (5) not contraindicated to physical activity. Participants meeting the inclusion criteria will be randomly divided into two groups. The first group of women will undergo circuit training, consisting of exercises performed on 7 machines arranged in a circuit. Thanks to the use of adequate software the machines will automatically adjust their parameters, such as seat height or resistance to the exercising person, and the training progress will be individually monitored. The planned training will last for 3 months, during which the patients will exercise 3 times a week for 30 minutes (2 circuits will be done during each session). The planned duration of the training session will be controlled (one minute for strength exercises, four minutes for endurance exercises and a 30-second break between each exercise). In the training group, one-repetition maximum exercise test (1RM) will be performed to determine the appropriate training load and later after the program to verify the increase in muscle strength. The range of maximum heart rate (HRmax) will also be determined in all exercising women. The second group of women, who will be asked to maintain their current level of physical activity and their diet for a period of 3 months will serve as a control group. Before and after the training program in all participants of the study pulse wave velocity, anthropometric parameters and body composition will be assessed. Concurrently venous blood will be taken to determine biochemical indicators related to carbohydrate and lipid metabolism, insulin resistance, vascular endothelium function, inflammation and adipocytokines and myokines. In both groups of women, the questioners concerning dietary intake and the level of daily physical activity will be administered.

Results will be subjected to analysis involving descriptive, and advanced statistic method among them analysis of correlations, regression, variance and cluster analysis. All calculations and statistics will be performed using TIBCO Statistica 13.3 software (TIBCO).


Condition or disease Intervention/treatment Phase
Insulin Resistance Behavioral: Circuit training (combination of strength and endurance exercises) Not Applicable

Detailed Description:

The training program will be performed on 7 machinesin a circuit. The devices will be controlled by a pre-programmed chip card, so that they will automatically adjust their parameters, such as seat height or resistance to the patient, and it will be possible to monitor the training progress of exercising women and their presence during training. Only two people will be allowed in the room during the training. The planned duration of the exercises will be controlled (one minute for strength exercises, four minutes for endurance exercisesand a 30-second break between each exercise) and for each trainee the load will be dosed using the electronic resistance motor system. Exercises in the training program are planned in such a way that the different muscle groups of women exercising are loaded alternately, which will ensure comprehensive training of the whole body. The range of movement, exercise duration and breaks will be controlled automatically by the system and the software of the devices and will not require additional training attention.

In the training group, one-repetition maximum exercise test (1RM) will be performed to determine the appropriate training load and later after the program to verify the increase in muscle strength.

The HR max range will be determined for exercising women by the indirect method using the formula: training HR = 220 -subject age.

The characteristics of exercises in the circuit:

  1. The training circuit starts with an exercise on a cycloergometer -"bike", which lasts 4 minutes.
  2. The second exercise -"abdominal crunch", shapes the strength of the abdominal muscles and together with exercise number six, it not only improves muscle strength parameters, but also shapes balance and maintains the correct position of the body.
  3. The third exercisein a circuit-"leg curl", shapes the muscular strength of the back of the thigh (biceps femoris muscleand muscles adjacent to it).
  4. The fourth exercise -"lat pulldown", trains the strength of the latissimus dorsi muscle, shoulder girdle muscles and upper chest. In addition to improving the strength and function of the muscles mentioned above, the exercise also perfectly stimulates the auxiliary respiratory muscles.
  5. Fifth exercise -"crosswalker".This exercise trainsmost of the body's muscles, itlasts 4 minutes and, like training on a cycloergometer, primarily shapes thephysical capacity.
  6. The sixth exercise -"back extension"trains the strength of the abdominal muscles, erector spinae and other muscles of a back.
  7. The seventh exercise -"legabductor", the last in the series, is an exercise that shapes the gluteal muscles, as well as hip adductor and abductor muscles. This exercise fulfills the function of shaping strength and securing the hip joint, by training the muscle parts less frequently used in everyday life, the more difficult to be kept fit as the years go by and the level of physical activity decreases.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study is designed as a prospective randomized clinical trial where subjects are randomally allocated to intervention group (study) or non-intervention group (control).
Masking: Single (Care Provider)
Masking Description: The qualifying physician does not know which of the examined persons will be allocated in the intervention or in the control group.
Primary Purpose: Basic Science
Official Title: The Effect of 12-week Circuit Training (Combination of Strength and Endurance Exercises) on Insulin Sensitivity and Vascular Endothelial Function in Women With Insulin Resistance
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
40 women with insulin resistance aged 25-45, BMI 18,5-29,9 will perform, for a period of 3 months, 3 times a week, strength training, interspersed with bouts of endurance exercise carried out on circuit machines integrated with the Milon computer software.
Behavioral: Circuit training (combination of strength and endurance exercises)
The intervention will last 3 months, exercises will take place 3 times a week and will consist of strength exercises, interspersed with bouts of endurance exercise carried out on circuit machines integrated with the Milon computer software for a total of 30 minutes per session.
Other Name: Circuit training on machines integrated with the Milon computer software

No Intervention: Control
40 women with insulin resistance aged 25-45, BMI 18,5-29,9 will be asked to maintain their current level of physical activity and their diet for a period of 3 months.



Primary Outcome Measures :
  1. Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: pre-intervention ]
  2. Homeostasis model assessment of insulin resistance (HOMA-IR) [ Time Frame: 48 hours after the intervention ]
  3. HbA1C [mmol/mol] [ Time Frame: pre-intervention ]
    ELISA

  4. HbA1C [mmol/mol] [ Time Frame: 48 hours after the intervention ]
    ELISA

  5. Insuline [mU/ml] [ Time Frame: pre-intervention ]
    Radioimmunoassay

  6. Insuline [mU/ml] [ Time Frame: 48 hours after the intervention ]
    Radioimmunoassay

  7. Systolic and diastolic blood pressure [mmHg] [ Time Frame: pre-intervention ]
  8. Systolic and diastolic blood pressure [mmHg] [ Time Frame: 48 hours after the intervention ]
  9. Pulse wave velocity (PWV) [m/s] [ Time Frame: pre-intervention ]
    PWV will be performed using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia.

  10. Pulse wave velocity (PWV) [m/s] [ Time Frame: 48 hours after the intervention ]
    PWV will be performed using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia.

  11. Glucose, Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l] [ Time Frame: pre-intervention ]
    Dimension Flex Reagent Cartridge

  12. Glucose, Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l] [ Time Frame: 48 hours after the intervention ]
    Dimension Flex Reagent Cartridge

  13. Irisin, Visfatin, Retinol-binding protein 4 (RBP-4) [pg/ml] [ Time Frame: pre-intervention ]
    ELISA

  14. Irisin, Visfatin, Retinol-binding protein 4 (RBP-4) [pg/ml] [ Time Frame: 48 hours after the intervention ]
    ELISA

  15. Apelin [ng/ml] [ Time Frame: pre-intervention ]
    ELISA

  16. Apelin [ng/ml] [ Time Frame: 48 hours after the intervention ]
    ELISA

  17. C Reactive Protein (hsCRP) [mg/l] [ Time Frame: pre-intervention ]
    ELISA

  18. C Reactive Protein (hsCRP) [mg/l] [ Time Frame: 48 hours after the intervention ]
    ELISA

  19. Interleukin-6 (IL-6), Interleukin-10 (IL-10) [pg/ml] [ Time Frame: pre-intervention ]
    ELISA

  20. Interleukin-6 (IL-6), Interleukin-10 (IL-10) [pg/ml] [ Time Frame: 48 hours after the intervention ]
    ELISA

  21. Endothelial nitric oxide synthase (eNOS) [ng/ml] [ Time Frame: pre-intervention ]
    ELISA

  22. Endothelial nitric oxide synthase (eNOS) [ng/ml] [ Time Frame: 48 hours after the intervention ]
    ELISA

  23. Muscle strength [kg] [ Time Frame: pre-intervention ]
    Test 1RM will be performed for following groups of muscles: abdominal muscles; back of the thigh (biceps femoris muscle and muscles adjacent to it); latissimus dorsi muscle, shoulder girdle muscles and upper chest; erector spinae and other muscles of a back; gluteal muscles, hip adductor and abductor muscles.

  24. Muscle strength [kg] [ Time Frame: 48 hours after the intervention ]
    Test 1RM will be performed for following groups of muscles: abdominal muscles; back of the thigh (biceps femoris muscle and muscles adjacent to it); latissimus dorsi muscle, shoulder girdle muscles and upper chest; erector spinae and other muscles of a back; gluteal muscles, hip adductor and abductor muscles.


Secondary Outcome Measures :
  1. Plantar stiffness [N/m] [ Time Frame: pre-intervention ]
    Biomechanical properties will be assessed with myotonometer device.

  2. Plantar stiffness [N/m] [ Time Frame: 48 hours after the intervention ]
    Biomechanical properties will be assessed with myotonometer device.

  3. State of tension of erector spinae muscles [Hz] [ Time Frame: pre-intervention ]
    Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.

  4. State of tension of erector spinae muscles [Hz] [ Time Frame: 48 hours after the intervention ]
    Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.

  5. Low back pain intensity: questionnaire [ Time Frame: pre-intervention ]
    Visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable

  6. Low back pain intensity: questionnaire [ Time Frame: 48 hours after the intervention ]
    Visual analogue scale (VAS) pain intensity questionare (reporting a score on a 10-point scale, the minimum (0) means no pain and the maximum (10) means a worst pain imaginable

  7. Disability caused by pain in the spine [ Time Frame: pre-intervention ]
    Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.

  8. Disability caused by pain in the spine [ Time Frame: 48 hours after the intervention ]
    Oswestry questionnaire. When completing the questionnaire, the subject answers questions concerning: pain intensity, independence, lifting objects, walking, sitting, standing, sleeping, social life, sexual activity and traveling. The answers to the questions help to classify how limited the functioning of the patient is while performing certain activities. Responses are graded from 0 to 5. The overall score is given on a 0-50 point scale, where the higher the score, the greater the disability.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women,
  • age: 25-45years,
  • menstruating,
  • BMI 18,5-29,9 kg/m2,
  • insulin resistance based on HOMA -IR (cut-off point 2.5),
  • not contraindicated to physical activity.

Exclusion Criteria:

  • type 1 and 2 diabetes,
  • poorly controlled hypertension (mean SBP >140mmHg and/or mean DBP >90mmHg) over the last month and/or need to modify the pharmacological treatment,
  • obesity: BMI > 30 kg/m2,
  • lipid disorders requiring implementation of pharmacological treatment in the last 3 months before or during observation,
  • a positive history of ischemic heart disease, carotid atherosclerosis and / or lower limb atherosclerosis,
  • clinically significant arrhythmias or conduction disorders,
  • chronickidney disease,
  • clinically significant liver dysfunction,
  • acute or chronic, clinically manifest inflammatory process,
  • an acute infection in the last month,
  • cancer,
  • taking dietary supplements within a month before inclusion and during observation,
  • taking medication that could interfere with the results of the tests,
  • other conditions that may pose any risk to the patient during the observation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528693


Contacts
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Contact: Marzena Ratajczak, PhD +48 604 77 38 16 mratajczak@awf.poznan.pl
Contact: Joanna Karolkiewicz, PhD +48 508 127 961 karolkiewicz@awf.poznan.pl

Locations
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Poland
Poznan University of Physical Education Recruiting
Poznań, Poland, 61-871
Contact: Marzena Ratajczak, PhD    +48 604 77 38 16    mratajczak@awf.poznan.pl   
Principal Investigator: Marzena Ratajczak, PhD         
Principal Investigator: Joanna Karolkiewicz, PhD         
Principal Investigator: Monika Krzywicka, PhD         
Principal Investigator: Monika Szulińska, PhD         
Principal Investigator: Dominika Musiałowska         
Sponsors and Collaborators
Poznan University of Physical Education
Poznan University of Medical Sciences
Publications:
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Responsible Party: Marzena Ratajczak, assistant professor, Poznan University of Physical Education
ClinicalTrials.gov Identifier: NCT04528693    
Other Study ID Numbers: PoznanUPhyEd no. 4
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marzena Ratajczak, Poznan University of Physical Education:
circuit training
combined training
endothelial function
insulin sensitivity
lipid metabolism
inflammation
myokines
plantar stifness
back pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases