NCT05315037

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

March 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

March 29, 2022

Last Update Submit

May 9, 2024

Conditions

Keywords

Resistance Training in type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Assess glucose response to different resistance training methods

    Blood glucose

    3 months

Secondary Outcomes (1)

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

    3 months

Study Arms (1)

Resistance Training

OTHER

Bench press, Deadlift, Seated overhead press machine

Other: Resistance Training

Interventions

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

Resistance Training

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • Physical limitation that may impede ability to complete study procedures
  • Non-English-speaking individual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Norton Healthcare

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Brad J Thrasher, DO

CONTACT

Sarah P King, BS,BA

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 7, 2022

Study Start

August 1, 2023

Primary Completion

June 1, 2025

Study Completion

December 30, 2025

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations