Type 2 Diabetes MellitusNCT04383314
Targeting Hyaluronan Accumulation Through Exercise in T2DM
A study testing 10-week exercise program on HA accumulation in people with Type 2 Diabetes Mellitus, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- 10-week exercise program on HA accumulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Aug 2024
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Longitudinal, Single-center Study Investigating the Effects of Exercise on Hyaluronan Accumulation in Skeletal Muscle in Individuals With Type 2 Diabetes Mellitus
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.
Read the 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
- Being tested
- 10-week exercise program on HA accumulation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-week exercise program on HA accumulationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program Group | Experimental | 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. Receives: Behavioral: 10-week exercise program on HA accumulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Level of Hyaluronan accumulation in calf muscle of participants
Hyaluronan accumulation (HA) in calf muscle will be assessed using 3D T1ρ and T2-weighted MR scans on a 3T whole-body clinical MRI scanner (Prisma, Siemens Healthcare, Erlangen, Germany) with a 15-channel knee coil (QED, Cleveland OH). The total scan time is expected to be 29 min, 30 s. The sequence acquisition parameters will be as follows: TR/TE = 1500 ms/3.78 ms, flip angle = 8°, field of view (FOV) = 140 mm2, spin-lock lengths (TSLs)=0,10ms, 20ms, 30ms, 40ms and 60ms, spin-lock frequency=500Hz matrix size 256 × 128 × 64, slice thickness = 2 m.
Measured: Week 1, Week 11
Change in the Level of Calf muscle stiffness in participants
Calf muscle stiffness will measured using a previously validated device (FDA product classification: non-powered goniometer, 510K exempt). Briefly, subjects are positioned supine with the knee extended and their leg is secured by Velcro straps. Torques of 15, 20 and 25 Nm are applied using a hand-held force gauge (FDK 40, Wagner Instruments, Greenwich, CT) and resultant angular kinematics are measured using a digital inclinometer (Checkpoint Inc., Torrance, CA). Three cycles of testing are performed in ascending order of force application and resultant peak dorsiflexion range of motion is recorded at each force level. Calf muscle stiffness is calculated as the slope of the resultant curves over the 15 to 25 Nm intervals. This device has demonstrated high convergent validity compared to motion analysis (Intraclass correlation coefficient (ICC [2,k])> 0.95).
Measured: Week 1, Week 11
Change in the Degree of Passive ankle mobility in participants
Passive ankle mobility will measured using a previously validated device (FDA product classification: non-powered goniometer, 510K exempt). Briefly, subjects are positioned supine with the knee extended and their leg is secured by Velcro straps. The axis of rotation of the device is then adjusted in the anteroposterior and supero-inferior directions to approximate the ankle axis of rotation determined by palpation of the distal tips of the medial and lateral malleoli. Torques of 15, 20 and 25 Nm are applied using a hand-held force gauge (FDK 40, Wagner Instruments, Greenwich, CT) and resultant angular kinematics are measured using a digital inclinometer (Checkpoint Inc., Torrance, CA). Three cycles of testing are performed in ascending order of force application and resultant peak dorsiflexion range of motion is recorded at each force level.
Measured: Week 1, Week 11
Change in the Level of Calf muscle strength in participants
Calf muscle strength, quantified as peak plantarflexion torque. An isokinetic dynamometer (Biodex, Shirley, NY) will be used to quantify peak isokinetic torque of the calf muscle at 60 degrees per second in participants' available range of motion (FDA product classification: AC powered dynamometer, 510K exempt). All participants will be tested in the seated position. Three practice trials will be given, after which peak plantarflexion torque will be recorded from the highest of three trials. With these procedures, coefficient of variation of <10% has been reported in individuals with T2DM, indicating good repeatability.
Measured: Week 1, Week 11
Change in the Change in Gait (Stride length) of participants after intervention
The study will use a motion capture system to collect kinematic (marker) and kinetic (force plate and pressure plate) data as subjects walk barefoot at self-selected speed along a 10 m walkway. A minimum of five successful trials will be collected for each subject. A trial will be considered successful if the subject made clean force plate contact on the tested side without targeting. Stride length will be defined as the distance between consecutive initial contacts of the same limb and will be calculated using Visual3D software (C-motion Inc., USA).
Measured: Week 1, Week 11
Change in the Change in Gait (Walking Speed) of participants after intervention
The study will use a motion capture system to collect kinematic (marker) and kinetic (force plate and pressure plate) data as subjects walk barefoot at self-selected speed along a 10 m walkway. A minimum of five successful trials will be collected for each subject. A trial will be considered successful if the subject made clean force plate contact on the tested side without targeting. Walking speed will be defined as distance travelled in unit time and will be calculated using Visual3D software (C-motion Inc., USA).
Measured: Week 1, Week 11
Change in Self-reported physical function of participants after intervention
This will be evaluated using Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference scales. PROMIS is a computer adaptive testing outcomes instrument, generated after exhaustive review, and the application of item response theory to calibrate the individual items. The higher the score indicate higher levels of physical functioning. All PROMIS measures are scored using the final re-centered item response theory (IRT) item parameters and transformed to the T-score metric (mean=50, SD=10).
Measured: Week 1, Week 11
Secondary outcomes (5)
Change in the Glycemic Control
Glycemic control will be assessed with Hemoglobin A1c test. Participants will be asked to give 1 mL of blood at baseline and after intervention.
Measured: Week 2, Week 12
Change in the Number of participants with increased physical activity
Physical activity will be assessed using a wrist-worn triaxial accelerometer (Actigraph). Step counts, and percent of time in sedentary, light and moderate / vigorous physical activity will be quantified for each participant. The actigraph will be worn for two weeks on the wrist, participants may take it off when bathing and sleeping.
Measured: Week 1, Week 11
Number of Participants who adhere to the Exercise program
Number of sessions attended will be calculated and used to calculate adherence. A systematic review of exercise training indicates attrition rates of <20% and adherence rates of >75% in individuals with T2DM.
Measured: Week 12
Number of participants with Neuropathy
The Michigan Neuropathy Screening Instrument will be used to screen for the presence of peripheral neuropathy. The Michigan Neuropathy Screening Instrument (MNSI) is used to assess distal symmetrical peripheral neuropathy in diabetes. It includes two separate assessments: a 15-item self-administered questionnaire and a lower extremity examination that includes inspection and assessment of vibratory sensation and ankle reflexes
Measured: Week 1
Number of participants with Osteoarthritis
Presence of knee osteoarthritis may affect levels of serum HA. American College of Rheumatology (ACR) Clinical Classification Criteria will be used to screen for the presence of knee osteoarthritis. History and physical examination will be used to screen for knee osteoarthritis using the following criteria: Pain in the knee and three of the following: 1) >50 years of age, 2) Less than 30 minutes of morning stiffness, 3) Crepitus on active motion, 4) Bony tenderness, 5) Bony enlargement, 6) No palpable warmth of synovium.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Sep 2021
- Primary completion31 May 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Smita Rao, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383314
- Sponsor's protocol ID
- 19-01913
- Status last verified
- Jan 2025
- First submitted
- 6 May 2020
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Single-center Study Investigating the Effects of Exercise on Hyaluronan Accumulation in Skeletal Muscle in Individuals With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04383314
- Acronym / sponsor ID
- 19-01913
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 May 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Program Group | Experimental | Behavioral: 10-week exercise program on HA accumulationParticipants 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| 10-week exercise program on HA accumulationA 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. | Behavioural | Exercise Program Group |
Primary outcome
Change in the Level of Hyaluronan accumulation in calf muscle of participants
Time frame: Week 1, Week 11
Hyaluronan accumulation (HA) in calf muscle will be assessed using 3D T1ρ and T2-weighted MR scans on a 3T whole-body clinical MRI scanner (Prisma, Siemens Healthcare, Erlangen, Germany) with a 15-channel knee coil (QED, Cleveland OH). The total scan time is expected to be 29 min, 30 s. The sequence acquisition parameters will be as follows: TR/TE = 1500 ms/3.78 ms, flip angle = 8°, field of view (FOV) = 140 mm2, spin-lock lengths (TSLs)=0,10ms, 20ms, 30ms, 40ms and 60ms, spin-lock frequency=500Hz matrix size 256 × 128 × 64, slice thickness = 2 m.
Change in the Level of Calf muscle stiffness in participants
Time frame: Week 1, Week 11
Calf muscle stiffness will measured using a previously validated device (FDA product classification: non-powered goniometer, 510K exempt). Briefly, subjects are positioned supine with the knee extended and their leg is secured by Velcro straps. Torques of 15, 20 and 25 Nm are applied using a hand-held force gauge (FDK 40, Wagner Instruments, Greenwich, CT) and resultant angular kinematics are measured using a digital inclinometer (Checkpoint Inc., Torrance, CA). Three cycles of testing are performed in ascending order of force application and resultant peak dorsiflexion range of motion is recorded at each force level. Calf muscle stiffness is calculated as the slope of the resultant curves over the 15 to 25 Nm intervals. This device has demonstrated high convergent validity compared to motion analysis (Intraclass correlation coefficient (ICC [2,k])> 0.95).
Change in the Degree of Passive ankle mobility in participants
Time frame: Week 1, Week 11
Passive ankle mobility will measured using a previously validated device (FDA product classification: non-powered goniometer, 510K exempt). Briefly, subjects are positioned supine with the knee extended and their leg is secured by Velcro straps. The axis of rotation of the device is then adjusted in the anteroposterior and supero-inferior directions to approximate the ankle axis of rotation determined by palpation of the distal tips of the medial and lateral malleoli. Torques of 15, 20 and 25 Nm are applied using a hand-held force gauge (FDK 40, Wagner Instruments, Greenwich, CT) and resultant angular kinematics are measured using a digital inclinometer (Checkpoint Inc., Torrance, CA). Three cycles of testing are performed in ascending order of force application and resultant peak dorsiflexion range of motion is recorded at each force level.
Change in the Level of Calf muscle strength in participants
Time frame: Week 1, Week 11
Calf muscle strength, quantified as peak plantarflexion torque. An isokinetic dynamometer (Biodex, Shirley, NY) will be used to quantify peak isokinetic torque of the calf muscle at 60 degrees per second in participants' available range of motion (FDA product classification: AC powered dynamometer, 510K exempt). All participants will be tested in the seated position. Three practice trials will be given, after which peak plantarflexion torque will be recorded from the highest of three trials. With these procedures, coefficient of variation of <10% has been reported in individuals with T2DM, indicating good repeatability.
Change in the Change in Gait (Stride length) of participants after intervention
Time frame: Week 1, Week 11
The study will use a motion capture system to collect kinematic (marker) and kinetic (force plate and pressure plate) data as subjects walk barefoot at self-selected speed along a 10 m walkway. A minimum of five successful trials will be collected for each subject. A trial will be considered successful if the subject made clean force plate contact on the tested side without targeting. Stride length will be defined as the distance between consecutive initial contacts of the same limb and will be calculated using Visual3D software (C-motion Inc., USA).
Change in the Change in Gait (Walking Speed) of participants after intervention
Time frame: Week 1, Week 11
The study will use a motion capture system to collect kinematic (marker) and kinetic (force plate and pressure plate) data as subjects walk barefoot at self-selected speed along a 10 m walkway. A minimum of five successful trials will be collected for each subject. A trial will be considered successful if the subject made clean force plate contact on the tested side without targeting. Walking speed will be defined as distance travelled in unit time and will be calculated using Visual3D software (C-motion Inc., USA).
Change in Self-reported physical function of participants after intervention
Time frame: Week 1, Week 11
This will be evaluated using Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function and Pain Interference scales. PROMIS is a computer adaptive testing outcomes instrument, generated after exhaustive review, and the application of item response theory to calibrate the individual items. The higher the score indicate higher levels of physical functioning. All PROMIS measures are scored using the final re-centered item response theory (IRT) item parameters and transformed to the T-score metric (mean=50, SD=10).
5 secondary outcomes
Change in the Glycemic Control
Time frame: Week 2, Week 12
Change in the Number of participants with increased physical activity
Time frame: Week 1, Week 11
Number of Participants who adhere to the Exercise program
Time frame: Week 12
Number of participants with Neuropathy
Time frame: Week 1
Number of participants with Osteoarthritis
Time frame: Week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Smita Rao, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10-week exercise program on HA accumulation in people with Type 2 Diabetes Mellitus, run by NYU Langone Health at 1 site 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Level of Hyaluronan accumulation in calf muscle of participants (time frame: Week 1, Week 11). The study lists 7 primary outcomes in all. 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 31 Jan 2025.