Clinical trial NCT00780559: Improving Neuropathy and Mobility in People With Early Diabetes
Official title: Improving Neuropathy and Mobility in Subjects With Early Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Physical Activity
Keywords: Neuropathy
diabetes
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Maryland, College Park
name: University of Michigan
First posted: 2008-10-27
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel treatments
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Six Minute Walk (6MW) Test
timeFrame: Six Months
measure: Change in 6-Minute-Walk Test Measured in Feet Between Baseline and 12 Months
timeFrame: Baseline and 12 Months
Secondary outcomes:
measure: Intraepidermal Nerve Fiber Density (Distal Leg)
timeFrame: 12 Months
measure: Intraepidermal Nerve Fiber Density (IENFD) at the Proximal Thigh
timeFrame: 12 Months
Other outcomes:
measure: Change in Physical Activity (PA) at 12 Months as Measured by the CHAMPS (Community Health Activities Model Program for Seniors) Activity Scale
timeFrame: Baseline and 12 Months
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: James W Russell, MD
role: PRINCIPAL_INVESTIGATOR
References: