NCT04383314

Targeting Hyaluronan Accumulation Through Exercise in T2DM

A Longitudinal, Single-center Study Investigating the Effects of Exercise on Hyaluronan Accumulation in Skeletal Muscle in Individuals With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A pilot longitudinal study to examine hyaluronan (HA) accumulation in muscles of individuals with Type 2 diabetes mellitus (T2DM), and the effects of exercise on HA accumulation, muscle stiffness, strength, ankle joint mobility, and physical function. HA accumulation will be assessed non- invasively using magnetic resonance imaging.

Detailed description

This single-center, longitudinal design study uses MRI to evaluate the mechanistic effects of exercise on skeletal muscle function. Twenty-five T2DM patients will be enrolled and be prescribed a 10-week exercise program. The exercise program will comprise aerobic and resistance components; a moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention. MRI data will be acquired at baseline and before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	10-week exercise program on HA accumulation	A 10-week exercise program with both aerobic and resistance components, based on the American College of Sports Medicine (2010), will be individually prescribed to 25 T2DM patients.Exercise training will be performed on Days 1 and 2 of each week under the supervision of licensed physical therapists. Participants will have the choice of using a treadmill or a recumbent stepper. The physical therapists will monitor blood glucose level, blood pressure, heart rate, and RPE during each exercise session. Participants will be asked to exercise at home on Day 3 of each week, and will not be supervised by the study team.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-05-31
• Completion: 2024-08-31
• First posted: 2020-05-12
• Last updated: 2025-01-31

Locations

1 site across 1 country: United States