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Resistance Training in Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring Resistance Training in type 1 diabetes

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norton Healthcare
  • University of Louisville

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Resistance Training

Arm Description

Bench press, Deadlift, Seated overhead press machine

Outcomes

Primary Outcome Measures

Assess glucose response to different resistance training methods
Blood glucose

Secondary Outcome Measures

To assess for correlation between lactate and glucose using different resistance training methods
Blood glucose, lactate

Full Information

First Posted
March 29, 2022
Last Updated
February 12, 2023
Sponsor
University of Louisville
Collaborators
Norton Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT05315037
Brief Title
Resistance Training in Type 1 Diabetes Mellitus
Official Title
Resistance Training Methods Impact On Glycemic Excursion and Metabolic Pathways in Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
Norton Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Resistance Training in type 1 diabetes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Resistance Training
Arm Type
Other
Arm Description
Bench press, Deadlift, Seated overhead press machine
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Assess glucose response to different resistance training methods
Description
Blood glucose
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To assess for correlation between lactate and glucose using different resistance training methods
Description
Blood glucose, lactate
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brad J Thrasher, DO
Phone
5025883400
Email
bjthra01@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah P King, BS,BA
Phone
5026292721
Email
slpenn03@louisville.edu
Facility Information:
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad J Thrasher, DO
Phone
502-588-3400
Email
bjthra01@louisville.edu
First Name & Middle Initial & Last Name & Degree
Sarah P King, BA,BS
Phone
5026292721
Email
slpenn03@louisville.edu
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad J Thrasher, DO
Phone
502-588-3400
Email
bjthra01@louisville.edu
First Name & Middle Initial & Last Name & Degree
Sarah P King, BS,BA
Phone
5026292721
Email
slpenn03@louisville.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Resistance Training in Type 1 Diabetes Mellitus

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