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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05315037
Other study ID # 21.0565
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source University of Louisville
Contact Brad J Thrasher, DO
Phone 5025883400
Email bjthra01@louisville.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to learn how different resistance training programs affects blood sugar in young athletes with T1DM.


Description:

Strength and condition training to improve sport performance has been greatly emphasized over the past 20 years. Formal strength and conditioning (S&C) programming is performed by S&C coaches who are educated in the field of exercise program with the intentions to bring about particular athletic adaptations through exercise. S&C programs, previously limited to programs at the college and professional level, are now commonly seen in secondary school athletic programs. With such broad adoption, many athletes that manage chronic diseases, such as type 1 diabetes mellitus, are exposed to elements of these programs. Diabetes mellitus impacts more than 10% of the United States population. Of these, 5.2% have identified type 1 diabetes mellitus (T1DM) which includes approximately 210,000 individuals under the age of 20. In addition to insulin and dietary management, exercise and physical activity is recommended as an important therapeutic tool for most patients with T1DM. Physical activity has been shown to significantly improve glycemic control in individuals with diabetes. Additional benefits of exercise include improved cardiovascular fitness, muscle strength, insulin sensitivity and blood glucose control. S&C programs offer benefits to those living with T1DM as different exercises can be tailored to preserve health. However, there are no exercise prescription or guidelines specifically for adolescent athletes diagnosed with type 1 diabetes participating in strength and conditioning programs. Furthermore, there is no available data that states the predictability of glucose response and insulin needs to any of the specific strength and conditioning goals. Objective: To assess the impact of different strength and conditioning programming on glycemic control in athletes with T1DM. Primary Aim: Assess glucose response to different resistance training methods. Secondary Aims: To assess for correlation between lactate and glucose using different resistance training methods.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 30, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria: - = 13 years of age - =2 years from date of T1DM diagnosis - Prior exposure to strength and conditioning - HbA1C = 10% - Actively utilizing continuous glucose monitoring for diabetes management Exclusion Criteria: - Physical limitation that may impede ability to complete study procedures - Non-English-speaking individual

Study Design


Intervention

Other:
Resistance Training
Bench press: Exercise performed with participant lying supine with hands in prone position. Barbell is lowered vertically from fully extended elbow position to sternum, then returned to starting position. Barbell will be weighted with plates dependent on their strength and workout demands. Deadlift: Consists of gripping bar while in a squat position. Extension of ankles, knees, and hips while gripping the bar brings the weight up until joints are locked completing the exercise concentric portion. The eccentric lowering of the weight follows and consists of flexion of joints. Seated overhead press machine: This multi-joint exercise, deltoid and trapezius are the prime movers and triceps are secondary movers, with hands on the grips and a position allowing back and buttocks to be completely supported. They push against a load vertically until glenohumeral joint fully extends, then load is returned to starting position and process continues until all repetitions desired are achieved

Locations

Country Name City State
United States Norton Healthcare Louisville Kentucky
United States University of Louisville Louisville Kentucky

Sponsors (2)

Lead Sponsor Collaborator
University of Louisville Norton Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess glucose response to different resistance training methods Blood glucose 3 months
Secondary To assess for correlation between lactate and glucose using different resistance training methods Blood glucose, lactate 3 months
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