Improving Neuropathy and Mobility in People With Early Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - 80
Updated:4/17/2018
Start Date:November 1, 2009
End Date:February 8, 2018

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Improving Neuropathy and Mobility in Subjects With Early Diabetes

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.

Inclusion Criteria:

- IGR at the time of screening or within three months of screening. This definition
includes patients with impaired fasting glucose (IFG), impaired glucose tolerance
(IGT), and early diabetes. Patients can be included if they have an increased risk for
diabetes with a HBA1C > or = 5.7% (using a method certified by the National
Glycohemoglobin Standardization Program), or they have diabetes with a HBA1C > or
equal to 6.5%, or an abnormal fasting venous glucose, or abnormal venous glucose
values following a 75 gram oral load. Glucose values are as defined (mg/dl): IFG
fasting greater than 100 mg/dl, IGT- fasting less than 126, 2 h 140-199, or diabetes -
fasting glucose > 126, 2 h > 200 based on the Standards for Medical Care in Diabetes
2010 by the American Diabetes Association.

- The 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 for neuropathy (determined by a medical history,
family history, history of medications, occupational history, history of exposure to
toxins, physical and neurological examinations, and laboratory studies).

- Clinical signs or symptoms of neuropathy as determined by the treating neurologists
history and physical exam, plus an abnormality of one of the following: nerve
conduction studies (NCS), Quantitative Sudomotor Autonomic Reflex Testing (QSART),
Quantitative Sensory Testing (QST), or IENFD.

- Age range from 30 to 80 years inclusive at the time of screening

- Medically stable at the time of enrollment.

- Able to participate in a 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 participation
in the study.

- 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.

- Current severe medical conditions that are active on the day of enrollment and would
affect a patient's ability to complete study. This may include active 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, active severe
obstructive or restrictive pulmonary disease, ongoing cancer treatment, renal failure
currently requiring dialysis, or 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 to Sign
Consent (ESC) tool.

- Significant other neurologic, rheumatological, neuromuscular, or other extremity
conditions that limit safe exercise or weight bearing.
We found this trial at
3
sites
Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-3100
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Ann Arbor, Michigan 48113
Phone: 734-763-8970
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Baltimore, Maryland 21201
Principal Investigator: James W Russell, MD
Phone: 410-032-6583
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