Targeting Hyaluronan Accumulation Through Exercise in T2DM

NCT ID: NCT04383314

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-08-31

Brief Summary

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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

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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

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise Program Group

Participants will be prescribed an individualized 10-week exercise program with both aerobic and resistance components, based on the American College of Sports Medicine (ACSM) Guidelines.

Group Type EXPERIMENTAL

10-week exercise program on HA accumulation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Be between the ages of 40 and 75
* Clinical diagnosis of Type 2 diabetes
* Have a BMI less than 40 kg/m2 (due to magnet bore restrictions)
* Able to walk unassisted

Exclusion Criteria

* Serious cardiac pathology or musculoskeletal problems that would limit exercise ability
* Current open wound or history of plantar ulcer for the last 3 months
* Partial foot amputations
* Inability to ambulate without assistive device
* Stroke or other central nervous system pathology
* Stage 2 hypertension (resting blood pressure \>160 systolic or \>100 diastolic)
* Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems).
* Subjects with alcoholism, chronic drug use, chronic gastrointestinal disease, or renal or hepatic impairment
* Pregnant women and children
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Smita Rao, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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19-01913

Identifier Type: -

Identifier Source: org_study_id

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