NCT05571384

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

December 5, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

September 23, 2022

Last Update Submit

December 4, 2025

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (4)

  • 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.

    Pre and post 16-week intervention

  • Oral Glucose Tolerance Test change within participant

    Glucose and Insulin response to bolus amount of glucose beverage

    Pre and post 16-week intervention

  • Body Composition change within participant

    Fat mass and lean mass

    Pre and post 16-week intervention

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

    sub maximal treadmill endurance test

    Pre and post 16-week intervention

Study Arms (1)

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.

Behavioral: high intensity body-weight circuit

Interventions

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.

high intensity body-weight circuit (HIBC)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennesaw State Univeristy

Kennesaw, Georgia, 30144, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 23, 2022

First Posted

October 7, 2022

Study Start

July 26, 2022

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

December 5, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations