Insulin ResistanceNCT04528693
The Effect of 12-week Circuit Training on Insulin Sensitivity and Endothelial Function in Women With Insulin Resistance
A study testing Circuit training (combination of strength and endurance exercises) in people with Insulin Resistance, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Circuit training (combination of strength and endurance exercises)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 sitePoland
- Study dates
- 17 Aug 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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:
- The training circuit starts with an exercise on a cycloergometer -"bike", which lasts 4 minutes.
- 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.
- The third exercisein a circuit-"leg curl", shapes the muscular strength of the back of the thigh (biceps femoris muscleand muscles adjacent to it).
- 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.
- Fifth exercise -"crosswalker".This exercise trainsmost of the body's muscles, itlasts 4 minutes and, like training on a cycloergometer, primarily shapes thephysical capacity.
- The sixth exercise -"back extension"trains the strength of the abdominal muscles, erector spinae and other muscles of a back.
- 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.
- Conditions
- Insulin Resistance
- Being tested
- Circuit training (combination of strength and endurance exercises)
- Keywords
- circuit training, combined training, endothelial function, insulin sensitivity, lipid metabolism, inflammation, myokines, plantar stifness, back pain
- Medical subject headings
- Insulin Resistance, Inflammation, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit training (combination of strength and endurance exercises)Behavioural
Also called Circuit training on machines integrated with the Milon computer software
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Circuit training (combination of strength and endurance exercises) |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: pre-intervention
Homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: 48 hours after the intervention
HbA1C [mmol/mol]
ELISA
Measured: pre-intervention
HbA1C [mmol/mol]
ELISA
Measured: 48 hours after the intervention
Insuline [mU/ml]
Radioimmunoassay
Measured: pre-intervention
Insuline [mU/ml]
Radioimmunoassay
Measured: 48 hours after the intervention
Systolic and diastolic blood pressure [mmHg]
Measured: pre-intervention
Systolic and diastolic blood pressure [mmHg]
Measured: 48 hours after the intervention
Pulse wave velocity (PWV) [m/s]
PWV will be performed using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia.
Measured: pre-intervention
Pulse wave velocity (PWV) [m/s]
PWV will be performed using the SphygmoCor Px (Atcor Medical Blood Pressure Analysis System, Sydney, Australia.
Measured: 48 hours after the intervention
Glucose, Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]
Dimension Flex Reagent Cartridge
Measured: pre-intervention
Glucose, Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) [mmol/l]
Dimension Flex Reagent Cartridge
Measured: 48 hours after the intervention
Irisin, Visfatin, Retinol-binding protein 4 (RBP-4) [pg/ml]
ELISA
Measured: pre-intervention
Irisin, Visfatin, Retinol-binding protein 4 (RBP-4) [pg/ml]
ELISA
Measured: 48 hours after the intervention
Apelin [ng/ml]
ELISA
Measured: pre-intervention
Apelin [ng/ml]
ELISA
Measured: 48 hours after the intervention
C Reactive Protein (hsCRP) [mg/l]
ELISA
Measured: pre-intervention
C Reactive Protein (hsCRP) [mg/l]
ELISA
Measured: 48 hours after the intervention
Interleukin-6 (IL-6), Interleukin-10 (IL-10) [pg/ml]
ELISA
Measured: pre-intervention
Interleukin-6 (IL-6), Interleukin-10 (IL-10) [pg/ml]
ELISA
Measured: 48 hours after the intervention
Endothelial nitric oxide synthase (eNOS) [ng/ml]
ELISA
Measured: pre-intervention
Endothelial nitric oxide synthase (eNOS) [ng/ml]
ELISA
Measured: 48 hours after the intervention
Muscle strength [kg]
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.
Measured: pre-intervention
Muscle strength [kg]
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.
Measured: 48 hours after the intervention
Secondary outcomes (8)
Plantar stiffness [N/m]
Biomechanical properties will be assessed with myotonometer device.
Measured: pre-intervention
Plantar stiffness [N/m]
Biomechanical properties will be assessed with myotonometer device.
Measured: 48 hours after the intervention
State of tension of erector spinae muscles [Hz]
Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.
Measured: pre-intervention
State of tension of erector spinae muscles [Hz]
Natural oscillation frequency [Hz], characterizing Tone or Tension will be assessed with myotonometer device.
Measured: 48 hours after the intervention
Low back pain intensity: questionnaire
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
Measured: pre-intervention
Low back pain intensity: questionnaire
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
Measured: 48 hours after the intervention
Disability caused by pain in the spine
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.
Measured: pre-intervention
Disability caused by pain in the spine
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.
Measured: 48 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start17 Aug 2020
- Primary completion31 Dec 2022
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Marzena Ratajczak, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528693
- Sponsor's protocol ID
- PoznanUPhyEd no. 4
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Srikanthan P, Karlamangla AS. Relative muscle mass is inversely associated with insulin resistance and prediabetes. Findings from the third National Health and Nutrition Examination Survey. J Clin Endocrinol Metab. 2011 Sep;96(9):2898-903. doi: 10.1210/jc.2011-0435. Epub 2011 Jul 21.
PubMed 21778224Bird SR, Hawley JA. Update on the effects of physical activity on insulin sensitivity in humans. BMJ Open Sport Exerc Med. 2017 Mar 1;2(1):e000143. doi: 10.1136/bmjsem-2016-000143. eCollection 2016.
PubMed 28879026Lambers S, Van Laethem C, Van Acker K, Calders P. Influence of combined exercise training on indices of obesity, diabetes and cardiovascular risk in type 2 diabetes patients. Clin Rehabil. 2008 Jun;22(6):483-92. doi: 10.1177/0269215508084582.
PubMed 18511528Oh KJ, Lee DS, Kim WK, Han BS, Lee SC, Bae KH. Metabolic Adaptation in Obesity and Type II Diabetes: Myokines, Adipokines and Hepatokines. Int J Mol Sci. 2016 Dec 22;18(1):8. doi: 10.3390/ijms18010008.
PubMed 28025491Ormazabal V, Nair S, Elfeky O, Aguayo C, Salomon C, Zuniga FA. Association between insulin resistance and the development of cardiovascular disease. Cardiovasc Diabetol. 2018 Aug 31;17(1):122. doi: 10.1186/s12933-018-0762-4.
PubMed 30170598Karolkiewicz J, Krzywicka M, Szulinska M, Musialik K, Musialowska D, Zielinski J, Bilska A, Ratajczak M. Effects of a Circuit Training Program on Myokine Levels in Insulin-Resistant Women: A Randomised Controlled Trial. J Diabetes Res. 2024 Nov 28;2024:6624919. doi: 10.1155/jdr/6624919. eCollection 2024.
PubMed 39640300Ratajczak M, Krzywicka M, Szulinska M, Musialowska D, Kusy K, Karolkiewicz J. Effects of 12-Week Combined Strength and Endurance Circuit Training Program on Insulin Sensitivity and Retinol-Binding Protein 4 in Women with Insulin-Resistance and Overweight or Mild Obesity: A Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2024 Jan 6;17:93-106. doi: 10.2147/DMSO.S432954. eCollection 2024.
PubMed 38204866
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04528693
- Acronym / sponsor ID
- PoznanUPhyEd no. 4
- Conditions
- Insulin Resistance
- Keywords
- circuit training, combined training, endothelial function, insulin sensitivity, lipid metabolism, inflammation, myokines, plantar stifness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- The training circuit starts with an exercise on a cycloergometer -"bike", which lasts 4 minutes.
- 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.
- The third exercisein a circuit-"leg curl", shapes the muscular strength of the back of the thigh (biceps femoris muscleand muscles adjacent to it).
- 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.
- Fifth exercise -"crosswalker".This exercise trainsmost of the body's muscles, itlasts 4 minutes and, like training on a cycloergometer, primarily shapes thephysical capacity.
- The sixth exercise -"back extension"trains the strength of the abdominal muscles, erector spinae and other muscles of a back.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Circuit training (combination of strength and endurance exercises)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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- women,
- age: 25-45years,
- menstruating,
- BMI 18,5-29,9 kg/m2,
- insulin resistance based on HOMA -IR (cut-off point 2.5),
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circuit training (combination of strength and endurance exercises)Also: Circuit training on machines integrated with the Milon computer softwareThe 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. | Behavioural | Intervention |
Primary outcome
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: pre-intervention
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 48 hours after the intervention
HbA1C [mmol/mol]
Time frame: pre-intervention
ELISA
HbA1C [mmol/mol]
Time frame: 48 hours after the intervention
ELISA
Insuline [mU/ml]
Time frame: pre-intervention
Radioimmunoassay
Insuline [mU/ml]
Time frame: 48 hours after the intervention
Radioimmunoassay
Systolic and diastolic blood pressure [mmHg]
Time frame: pre-intervention
Systolic and diastolic blood pressure [mmHg]
Time frame: 48 hours after the intervention
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.
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.
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
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
Irisin, Visfatin, Retinol-binding protein 4 (RBP-4) [pg/ml]
Time frame: pre-intervention
ELISA
Irisin, Visfatin, Retinol-binding protein 4 (RBP-4) [pg/ml]
Time frame: 48 hours after the intervention
ELISA
Apelin [ng/ml]
Time frame: pre-intervention
ELISA
Apelin [ng/ml]
Time frame: 48 hours after the intervention
ELISA
C Reactive Protein (hsCRP) [mg/l]
Time frame: pre-intervention
ELISA
C Reactive Protein (hsCRP) [mg/l]
Time frame: 48 hours after the intervention
ELISA
Interleukin-6 (IL-6), Interleukin-10 (IL-10) [pg/ml]
Time frame: pre-intervention
ELISA
Interleukin-6 (IL-6), Interleukin-10 (IL-10) [pg/ml]
Time frame: 48 hours after the intervention
ELISA
Endothelial nitric oxide synthase (eNOS) [ng/ml]
Time frame: pre-intervention
ELISA
Endothelial nitric oxide synthase (eNOS) [ng/ml]
Time frame: 48 hours after the intervention
ELISA
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.
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.
8 secondary outcomes
Plantar stiffness [N/m]
Time frame: pre-intervention
Plantar stiffness [N/m]
Time frame: 48 hours after the intervention
State of tension of erector spinae muscles [Hz]
Time frame: pre-intervention
State of tension of erector spinae muscles [Hz]
Time frame: 48 hours after the intervention
Low back pain intensity: questionnaire
Time frame: pre-intervention
Low back pain intensity: questionnaire
Time frame: 48 hours after the intervention
Disability caused by pain in the spine
Time frame: pre-intervention
Disability caused by pain in the spine
Time frame: 48 hours after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Background: PubMed 21778224Srikanthan P, Karlamangla AS. Relative muscle mass is inversely associated with insulin resistance and prediabetes. Findings from the third National Health and Nutrition Examination Survey. J Clin Endocrinol Metab. 2011 Sep;96(9):2898-903. doi: 10.1210/jc.2011-0435. Epub 2011 Jul 21.
- Background: PubMed 28879026Bird SR, Hawley JA. Update on the effects of physical activity on insulin sensitivity in humans. BMJ Open Sport Exerc Med. 2017 Mar 1;2(1):e000143. doi: 10.1136/bmjsem-2016-000143. eCollection 2016.
- Background: PubMed 18511528Lambers S, Van Laethem C, Van Acker K, Calders P. Influence of combined exercise training on indices of obesity, diabetes and cardiovascular risk in type 2 diabetes patients. Clin Rehabil. 2008 Jun;22(6):483-92. doi: 10.1177/0269215508084582.
- Background: PubMed 28025491Oh KJ, Lee DS, Kim WK, Han BS, Lee SC, Bae KH. Metabolic Adaptation in Obesity and Type II Diabetes: Myokines, Adipokines and Hepatokines. Int J Mol Sci. 2016 Dec 22;18(1):8. doi: 10.3390/ijms18010008.
- Background: PubMed 30170598Ormazabal V, Nair S, Elfeky O, Aguayo C, Salomon C, Zuniga FA. Association between insulin resistance and the development of cardiovascular disease. Cardiovasc Diabetol. 2018 Aug 31;17(1):122. doi: 10.1186/s12933-018-0762-4.
- Derived from this study: PubMed 39640300Karolkiewicz J, Krzywicka M, Szulinska M, Musialik K, Musialowska D, Zielinski J, Bilska A, Ratajczak M. Effects of a Circuit Training Program on Myokine Levels in Insulin-Resistant Women: A Randomised Controlled Trial. J Diabetes Res. 2024 Nov 28;2024:6624919. doi: 10.1155/jdr/6624919. eCollection 2024.
- Derived from this study: PubMed 38204866Ratajczak M, Krzywicka M, Szulinska M, Musialowska D, Kusy K, Karolkiewicz J. Effects of 12-Week Combined Strength and Endurance Circuit Training Program on Insulin Sensitivity and Retinol-Binding Protein 4 in Women with Insulin-Resistance and Overweight or Mild Obesity: A Randomized Controlled Trial. Diabetes Metab Syndr Obes. 2024 Jan 6;17:93-106. doi: 10.2147/DMSO.S432954. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit training (combination of strength and endurance exercises) in people with Insulin Resistance, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis model assessment of insulin resistance (HOMA-IR) (time frame: pre-intervention). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528693, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.