Reversing Diabetic Peripheral Neuropathy Through Exercise

NCT ID: NCT03686423

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-28
• Study Completion Date: 2022-06-30

Brief Summary

This project proposes a longitudinal design that uses multinuclear-MRI to evaluate the mechanistic effects of exercise on skeletal muscle function and peripheral nerve integrity in patients with diabetic peripheral neuropathy (DPN), and to determine whether exercise can reverse DPN symptoms. The investigators will prescribe a 10-week exercise program to 40 DPN patients. The investigators will acquire multinuclear-MRI data before and after the intervention that can provide mechanistic insight into the adaptations in lower leg muscle function and peripheral nerve integrity of patients with DPN, and their role in improving DPN symptoms following physical exercise intervention.

Conditions

Peripheral Neuropathy; Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Type 2 Diabetes and Clinical Symptoms of DPN

Patients will be individually prescribed to a 10-week exercise program with both aerobic and resistance components. Prior to beginning the intervention, patients will participate in a maximal graded exercise test (VO2R) using a cycle ergometer with a metabolic cart and integrated ECG.

Group Type: EXPERIMENTAL

Exercise Program

Intervention Type: PROCEDURE

The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention.

Interventions

Exercise Program

The exercise program will combine moderate intensity aerobic exercise with lower-extremity specific resistance training. A moderate level of intensity will be calculated based on results from a maximal graded exercise test (VO2R) conducted prior to the intervention.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Be between the ages of 40 and 70
• Clinical diagnosis of Type 2 diabetes
• Clinical diagnosis of DPN
• 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
• MNSI score < 1
• 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: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ryan Brown, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-00527

Identifier Type: -

Identifier Source: org_study_id