TerminatedNot Applicable

Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy

Stopped: Poor recruitment

United States3 participantsStarted 2016-05

Plain-language summary

Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system impairments that accelerate age-associated limitations in functional independence and the risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in balance and mobility because of limitations metabolic abnormalities. The constellation of impairments accompanying type 2 diabetes diminishes muscle function and performance including strength and power. Loss of strength at higher speeds of movement (deficit in power) occurs in neural activation of muscles, changes in muscle properties, and through in older individuals with DPN compared to older controls. Consequently, this deficit in speed dependent muscle power production leads to limitations in rapidly responding to sudden loss of balance stability to prevent falling. The goal of this pilot research program is to determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro improving balance and mobility functions and preventing falls in older adults with DPN. The investigators pan to use the results from this pilot study to design and implement a larger randomized control trial.

Who can participate

Age range

55 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * HbA1C of 5.7% to 9.0% or a fasting blood glucose of greater than or equal to 100 * Participants that are diabetic should be stable on medications for at least 3 months prior to entering the study * Neuropathy is most likely caused by impaired glucose regulation determined by medical or family history * Autonomic neuropathy as defined by Toronto Neuropathy Expert Group 2010/2011 consensus criteria * Medically stable at time of enrollment as determined by screening process Exclusion Criteria: * Neuropathy due to factors other than impaired glucose regulation determined by screening process * Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team * Severe Autonomic Neuropathy that would limit study participation * Musculoskeletal limitations that would preclude participation in balance assessment of protective stepping

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months

Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months

Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months

Change in protective stepping as determined by the number of steps it take to recover from a balance perturbation from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months

Trial details

NCT IDNCT02541838

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12

View on ClinicalTrials.gov More Diabetes Complications trials

Plain-language summary

Who can participate

Age range

55 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months

Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months

Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months

Change in protective stepping as determined by the number of steps it take to recover from a balance perturbation from baseline to 3 months and baseline to 6 months

Timeframe: baseline, 3 months, and 6 months