Clinical trial NCT04383314: Targeting Hyaluronan Accumulation Through Exercise in T2DM
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Level of Hyaluronan accumulation in calf muscle of participants
timeFrame: Week 1, Week 11
measure: Change in the Level of Calf muscle stiffness in participants
timeFrame: Week 1, Week 11
measure: Change in the Degree of Passive ankle mobility in participants
timeFrame: Week 1, Week 11
measure: Change in the Level of Calf muscle strength in participants
timeFrame: Week 1, Week 11
measure: Change in the Change in Gait (Stride length) of participants after intervention
timeFrame: Week 1, Week 11
measure: Change in the Change in Gait (Walking Speed) of participants after intervention
timeFrame: Week 1, Week 11
measure: Change in Self-reported physical function of participants after intervention
timeFrame: Week 1, Week 11
Secondary outcomes:
measure: Change in the Glycemic Control
timeFrame: Week 2, Week 12
measure: Change in the Number of participants with increased physical activity
timeFrame: Week 1, Week 11
measure: Number of Participants who adhere to the Exercise program
timeFrame: Week 12
measure: Number of participants with Neuropathy
timeFrame: Week 1
measure: Number of participants with Osteoarthritis
timeFrame: Week 1
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Smita Rao, PhD
role: PRINCIPAL_INVESTIGATOR
References: