Eligibility

Ages Eligible for Study

30 years to 75 years

Genders Eligible for Study

Both

Keywords

Neuropathy

Sponsors

Other

University of Michigan

Other

University of Maryland

U.S. Fed

Department of Veterans Affairs

Inclusion Criteria

- Impaired glucose regulation at the time of screening or within 2 years of screening.
This includes patients with impaired fasting glucose (IFG), impaired glucose
tolerance (IGT), and early diabetes. Definitions based on fasting venous glucose or
venous glucose values following a 75 gram oral load. IFG fasting >100mg/dl. IGT
fasting <126, 2 hour 140-199. Diabetes fasting < 126, 2 hour >200.

- HbA1c may be normal, but must be <8%.

- If diabetic subjects are on medication, they should be stable on medication for at
least 3 months prior to entering the study. Addition or change in antidiabetic
medications after enrollment does not affect participation or group assignment.

- No risk factors for other causes of neuropathy.

- Clinical signs or symptoms of neuropathy as determined by the treating neurologist's
history and physical exam PLUS an abnormality of the following: NCS, QSART, QST, or
IENFD.

- Age greater than 30 and less than 75 years at the time of screening.

- Medically stable at the time of enrollment.

- Able to participate in standing exercise program without constant standby monitoring.

- Women of childbearing potential must be using an acceptable method of contraception
to prevent pregnancy when they are enrolled in the study and must agree to continue
to practice an acceptable method of contraception for the duration of their study
participation.

- Patient must agree to taking an alternative medication to coumadin when undergoing a
skin biopsy.

- Willing to complete weekly self-report questionnaires.

- Willing to accept assignment to either training group.

- Willing and able to increase activity level and exercise independently at home.

Exclusion Criteria

- Pregnant women, prisoners, institutionalized subjects and other at risk subjects will
not be included in this study.

- taking insulin.

- Etiology of sensorimotor neuropathy other than IGR based on careful clinical and
laboratory evaluation.

- History of severe medical conditions likely to shorten lifespan or alter ability to
participate in the trial, for example advanced current ischemic heart disease (e.g.
angina or congestive heart failure), permanent residual lower extremity weakness or
loss of balance resulting from a stroke, severe obstructive or restrictive pulmonary
disease, or current cancer treatment, renal failure requiring dialysis, severe
ongoing peripheral vascular disease.

- An inability to understand or cooperate with the procedures of the trial or refusal
to sign the informed consent.

- Patients who are unable to answer questions correctly on the Evaluation ot Sign
Consent (ESC) tool.

- Significant other neurologic, rheumatological, neuromuscular, or other extremity
conditions that limit safe exercise or weight bearing.

Detailed Description

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.