- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05315037
Resistance Training in Type 1 Diabetes Mellitus
Resistance Training Methods Impact On Glycemic Excursion and Metabolic Pathways in Type 1 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brad J Thrasher, DO
- Phone Number: 5025883400
- Email: bjthra01@louisville.edu
Study Contact Backup
- Name: Sarah P King, BS,BA
- Phone Number: 5026292721
- Email: slpenn03@louisville.edu
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville
-
Contact:
- Sarah P King, BS,BA
- Phone Number: 5026292721
- Email: slpenn03@louisville.edu
-
Contact:
- Brad J Thrasher, DO
- Phone Number: 502-588-3400
- Email: bjthra01@louisville.edu
-
Louisville, Kentucky, United States, 40202
- Norton Healthcare
-
Contact:
- Brad J Thrasher, DO
- Phone Number: 502-588-3400
- Email: bjthra01@louisville.edu
-
Contact:
- Sarah P King, BA,BS
- Phone Number: 5026292721
- Email: slpenn03@louisville.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Resistance Training
Bench press, Deadlift, Seated overhead press machine
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess glucose response to different resistance training methods
Time Frame: 3 months
|
Blood glucose
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess for correlation between lactate and glucose using different resistance training methods
Time Frame: 3 months
|
Blood glucose, lactate
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.0565
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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