Type 1 DiabetesNCT05315037
Resistance Training in Type 1 Diabetes Mellitus
A study testing Resistance Training in people with Type 1 Diabetes, run by University of Louisville at 2 sites in United States.
Trial summary
The purpose of this study is to learn how different resistance training programs affects blood sugar in young athletes with T1DM. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2023to 30 Dec 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥ 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
Who cannot join
- Physical limitation that may impede ability to complete study procedures
- Non-English-speaking individual
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Norton Healthcare
Louisville, Kentucky, 40202
Brad J Thrasher, DO, 502-588-3400, bjthra01@louisville.edu
Sarah P King, BA,BS, 5026292721, slpenn03@louisville.edu
- Not yet recruiting
University of Louisville
Louisville, Kentucky, 40202
Brad J Thrasher, DO, 502-588-3400, bjthra01@louisville.edu
Sarah P King, BS,BA, 5026292721, slpenn03@louisville.edu
About this study
Official title: Resistance Training Methods Impact On Glycemic Excursion and Metabolic Pathways in Type 1 Diabetes Mellitus
The purpose of this study is to learn how different resistance training programs affects blood sugar in young athletes with T1DM.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Resistance Training
- Keywords
- Resistance Training in type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance TrainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training | Other | Bench press, Deadlift, Seated overhead press machine Receives: Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess glucose response to different resistance training methods
Blood glucose
Measured: 3 months
Secondary outcomes (1)
To assess for correlation between lactate and glucose using different resistance training methods
Blood glucose, lactate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Aug 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Blood glucose and lactate measurements will be collected prior to any physical activity, post workout, and then 10- and 20-minutes post workout. Using a standard lancet device, capillary blood glucose values will be obtained using a Contour Next Glucometer.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Norton Healthcare
- Responsible party
- Principal investigator, Bradly Thrasher, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315037
- Sponsor's protocol ID
- 21.0565
- Status last verified
- May 2024
- First submitted
- 29 Mar 2022
- Last updated
- 10 May 2024
- 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 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training Methods Impact On Glycemic Excursion and Metabolic Pathways in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05315037
- Acronym / sponsor ID
- 21.0565
- Conditions
- Type 1 Diabetes
- Keywords
- Resistance Training in type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Norton Healthcare
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 7 Apr 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.
The purpose of this study is to learn how different resistance training programs affects blood sugar in young athletes with T1DM.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blood glucose and lactate measurements will be collected prior to any physical activity, post workout, and then 10- and 20-minutes post workout. Using a standard lancet device, capillary blood glucose values will be obtained using a Contour Next Glucometer.
| Arm | Type | Receives |
|---|---|---|
| Resistance Training | Other | Other: Resistance TrainingBench press, Deadlift, Seated overhead press machine |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- Physical limitation that may impede ability to complete study procedures
- Non-English-speaking individual
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 |
|---|---|---|
| Resistance TrainingBench 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 | Other | Resistance Training |
Primary outcome
Assess glucose response to different resistance training methods
Time frame: 3 months
Blood glucose
1 secondary outcome
To assess for correlation between lactate and glucose using different resistance training methods
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training in people with Type 1 Diabetes, run by University of Louisville at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brad J Thrasher, DO (5025883400, bjthra01@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess glucose response to different resistance training methods (time frame: 3 months). 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 10 May 2024.