The purpose of this study is to determine if an individually tailored diet and physical enhancement program can improve mobility, physical activity, and neuropathy in people with early diabetes.
Neuropathy is the most common complication of diabetes mellitus. Impaired glucose regulation (IGR) is associated with development of peripheral neuropathy coupled with gait and mobility impairment that may be disabling for the patient. Recent novel data from the investigators' group indicates that improved diet and exercise can significantly improve and even reverse neuropathy associated with IGR, however this has not been tested as a specific intervention in a controlled diabetes complications trial. IGR includes patients with early type 2 diabetes mellitus (T2DM), impaired glucose tolerance (IGT), and impaired fasting glucose (IFG) based on standardized criteria for the diagnosis of T2DM. The investigators hypothesize that, compared to IGR participants advised to follow the current standard care recommendations on diet and exercise (Standard Care or "SC"), IGR participants undergoing a Tailored Diet and Physical Activity (TDPA) enhancement program will show greater improvement in the 6 minute walk test (6MW) and will show a greater reduction in markers of neuropathy progression e.g. intraepidermal nerve fiber density (IEFND). Furthermore, the investigators will test the hypothesis that improvement in measures of neuropathy, mobility function and physical activity (PA) will correlate strongly with each other and with improvement in specific measures of metabolic function, and weight loss. This proposal will permit us to determine if TDPA can improve mobility and induce nerve regeneration in subjects with early diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Subjects will receive an individually tailored diet and physical activity enhancement program
Subjects will be told to reduce their baseline weight by 7% and exercise for 150 minutes/week. There is no tailored, directed program.
University of Maryland
Baltimore, Maryland, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Six Minute Walk (6MW) Test
Measures distance covered by participant when walking at a brisk pace without running for six minutes in feet.
Time frame: Six Months
Change in 6-Minute-Walk Test Measured in Feet Between Baseline and 12 Months
Time frame: Baseline and 12 Months
Intraepidermal Nerve Fiber Density (Distal Leg)
Measure of the number of skin fibers/mm in the lower extremity (distal leg) at 12 months
Time frame: 12 Months
Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
Measure of the number of skin fibers/mm in the lower extremity (proximal thigh) at 12 months
Time frame: 12 Months
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