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Completed

NCT Number: NCT05571384

High Intensity Body-weight Circuit Training Feasibility and Efficacy for 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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kennesaw State Univeristy

Kennesaw, Georgia, 30144, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Those who have undergone any revascularization procedure
  • Diagnosed with or symptomatic of any renal, pulmonary, or cardiovascular disease (CVD)
  • Diagnosed cognitive dysfunction
  • Current smoker

Treatment and study plan

high intensity body-weight circuit

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. Body Composition change within participant

    Time frame: Pre and post 16-week intervention

    Fat mass and lean mass

  4. Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant

    Time frame: Pre and post 16-week intervention

    sub maximal treadmill endurance test

Sponsors and collaborators

Lead sponsor

Kennesaw State University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2022
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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