Type2diabetesNCT05571384
High Intensity Body-weight Circuit Training Feasibility and Efficacy for in Middle Aged Persons With Type 2 Diabetes
A study testing high intensity body-weight circuit in people with Type2diabetes, run by Kennesaw State University at 1 site in United States.
Trial summary
This research study proposes to quantify the efficacy of the novel high intensity body-weight circuit (HIBC) training intervention on metabolic profile, body composition, and health related fitness exercise in middle aged persons with type-2 diabetes (T2DM). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type2diabetes
- What is being tested?
- high intensity body-weight circuit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2022to 31 Jul 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent diagnosed of type 2 diabetes (T2DM) (within a year) * HbA1c of 6% or higher
- Non-insulin dependent
- No medicinal treatment
- Not currently undergoing a physical activity program in the last six months
- Received written medical clearance from overseeing physician
Who cannot join
- Those who have undergone any revascularization procedure
- Diagnosed with or symptomatic of any renal, pulmonary, or cardiovascular disease (CVD)
- Diagnosed cognitive dysfunction
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Intensity Body-weight Circuit Training Feasibility and Efficacy for Improving Metabolic Profile, Body Composition, and Health-Related Fitness in Middle Aged Persons With Type 2 Diabetes
This research study proposes to quantify the efficacy of the novel high intensity body-weight circuit (HIBC) training intervention on metabolic profile, body composition, and health related fitness exercise in middle aged persons with type-2 diabetes (T2DM). This research project is extremely relevant to public health, in that prevalence of T2DM continues to rise on a national and global scale, placing a heavy economic cost on both the healthcare industry and the individual patient in an age-dependent fashion. Results of this study may provide an effective and appealing alternative exercise intervention for cardiometabolic disease management in adults with T2DM, and have significant clinical and public health applications.
- Conditions
- Type2diabetes
- Being tested
- high intensity body-weight circuit
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity body-weight circuitBehavioural
Bodyweight and suspension training equipment (TRX® Fit System) with modified movements. Modified Squats: participants will be instructed to hold the handles of the band with arms extended, participants will then lean back in a standing position and perform a squat within a comfortable range of motion while weight is being distributed to the band. Modified Rows: participants will grab the bands with arms and legs extended. They will find a comfortable angle by which to perform a "row" (pulling the handles to the rib cage) with arms at a 45-degree angle. Modified Push-Ups: perform push-ups on their knees with a flat back and hands underneath their shoulders. They will be instructed to lower their chest towards the ground in a controlled manner and as far as comfort will allow them. Modified Crunches: participants will lay on their back with feet approximately 8-10 inches from their buttocks, and asked to lift their shoulders slightly off the ground.
| Study group | Role | What they receive |
|---|---|---|
| high intensity body-weight circuit (HIBC) | Experimental | HIBC Exercise Protocol- circuit repetition and order is as follows: modified squats (10 repetitions), modified rows (5 repetitions), crunches (10), and modified push-ups (5). The exercise sessions will involve repeating a series of repetitions of each movement in sequence, and completing as many sequences as possible in good form in the time allotted for the exercise (initially, 5 minutes). Three sessions per week will be completed at home. After three weeks of training, participants will be asked to add a fourth session each week. Initially, the HIBC sessions will be five minutes long, and the duration of the sessions will increase by one minute each week as tolerated beginning in week four, peaking at 10-minutes per session (warm up not included in this timing) as early as the eighth week of training. Session duration will be capped at 10-minutes. Receives: Behavioral: high intensity body-weight circuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change within participant
HbA1c (glycosylated Hemoglobin) indicates what the blood glucose environment was like for that past 3-months. This is the average life span of a red blood cell. High levels of blood glucose over a 3 month period lead to high HbA1c and vis versa. HbA1c can change as early as 14 weeks.
Measured: Pre and post 16-week intervention
Oral Glucose Tolerance Test change within participant
Glucose and Insulin response to bolus amount of glucose beverage
Measured: Pre and post 16-week intervention
Body Composition change within participant
Fat mass and lean mass
Measured: Pre and post 16-week intervention
Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant
sub maximal treadmill endurance test
Measured: Pre and post 16-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start26 Jul 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kennesaw State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Kliszczewicz, Kennesaw State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571384
- Sponsor's protocol ID
- KennesawSU
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Body-weight Circuit Training Feasibility and Efficacy for Improving Metabolic Profile, Body Composition, and Health-Related Fitness in Middle Aged Persons With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05571384
- Acronym / sponsor ID
- KennesawSU
- Conditions
- Type2diabetes
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kennesaw State UniversityUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 7 Oct 2022 (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.
This research study proposes to quantify the efficacy of the novel high intensity body-weight circuit (HIBC) training intervention on metabolic profile, body composition, and health related fitness exercise in middle aged persons with type-2 diabetes (T2DM). This research project is extremely relevant to public health, in that prevalence of T2DM continues to rise on a national and global scale, placing a heavy economic cost on both the healthcare industry and the individual patient in an age-dependent fashion. Results of this study may provide an effective and appealing alternative exercise intervention for cardiometabolic disease management in adults with T2DM, and have significant clinical and public health applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high intensity body-weight circuit (HIBC) | Experimental | Behavioral: high intensity body-weight circuitHIBC Exercise Protocol- circuit repetition and order is as follows: modified squats (10 repetitions), modified rows (5 repetitions), crunches (10), and modified push-ups (5). The exercise sessions will involve repeating a series of repetitions of each movement in sequence, and completing as many sequences as possible in good form in the time allotted for the exercise (initially, 5 minutes). Three sessions per week will be completed at home. After three weeks of training, participants will be asked to add a fourth session each week. Initially, the HIBC sessions will be five minutes long, and the duration of the sessions will increase by one minute each week as tolerated beginning in week four, peaking at 10-minutes per session (warm up not included in this timing) as early as the eighth week of training. Session duration will be capped at 10-minutes. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Recent diagnosed of type 2 diabetes (T2DM) (within a year) * HbA1c of 6% or higher
Key exclusion criteria (4 listed)
- Those who have undergone any revascularization procedure
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 |
|---|---|---|
| high intensity body-weight circuitBodyweight and suspension training equipment (TRX® Fit System) with modified movements. Modified Squats: participants will be instructed to hold the handles of the band with arms extended, participants will then lean back in a standing position and perform a squat within a comfortable range of motion while weight is being distributed to the band. Modified Rows: participants will grab the bands with arms and legs extended. They will find a comfortable angle by which to perform a "row" (pulling the handles to the rib cage) with arms at a 45-degree angle. Modified Push-Ups: perform push-ups on their knees with a flat back and hands underneath their shoulders. They will be instructed to lower their chest towards the ground in a controlled manner and as far as comfort will allow them. Modified Crunches: participants will lay on their back with feet approximately 8-10 inches from their buttocks, and asked to lift their shoulders slightly off the ground. | Behavioural | high intensity body-weight circuit (HIBC) |
Primary outcome
HbA1c change within participant
Time frame: Pre and post 16-week intervention
HbA1c (glycosylated Hemoglobin) indicates what the blood glucose environment was like for that past 3-months. This is the average life span of a red blood cell. High levels of blood glucose over a 3 month period lead to high HbA1c and vis versa. HbA1c can change as early as 14 weeks.
Oral Glucose Tolerance Test change within participant
Time frame: Pre and post 16-week intervention
Glucose and Insulin response to bolus amount of glucose beverage
Body Composition change within participant
Time frame: Pre and post 16-week intervention
Fat mass and lean mass
Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant
Time frame: Pre and post 16-week intervention
sub maximal treadmill endurance test
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 5 Dec 2025.
- Individual participant dataSharing planned: No
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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 high intensity body-weight circuit in people with Type2diabetes, run by Kennesaw State University at 1 site in United States.
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 5 inclusion and 4 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 5 Dec 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 United States. 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?
HbA1c change within participant (time frame: Pre and post 16-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.