Exercise program shows promise for diabetic nerve damage
NCT ID NCT01864460
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a program of diet, aerobic exercise, and balance training could improve nerve function and balance in people with prediabetes or early type 2 diabetes. About 61 participants were assigned to either the program or standard care. The goal was to see if these lifestyle changes could reduce symptoms like dizziness, poor balance, and falls, and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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61 people
The number who actually took part.
- Started
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Nov 2013
- Finished
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May 2019
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Impaired glucose regulation at the time of screening or within three months of screening. This definition includes patients with IFG, IGT, and early or mild DM2. Patients can be included if they have an increased risk for diabetes with a HBA1C greater than or equal to 5.7% (using a method certified by the National Glycohemoglobin Standardization Program), or they have diabetes with a HBA1C greater than or equal to 6.5%, or an abnormal fasting venous glucose, or abnormal venous glucose values following a 75 gram oral glucose load. Glucose values are as defined (mg/dl): IFG fasting glucose of 100-125 mg/dl, IGT- fasting less than 126, 2 h 140-199, or diabetes - fasting glucose greater than or equal to 126, or 2 h greater than or equal to 200 based on the Standards for Medical Care in Diabetes 2010 by the American Diabetes Association. * The HbA1c may be normal, but should be less than 9%. * 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 medication (if on medication) after enrollment does not affect participation or group assignment. * Impaired glucose regulation is the most likely cause of the neuropathy (determined by a medical history, family history, history of medications, occupational history, history of exposure to toxins (including significant alcohol use), physical and neurological examinations, and appropriate laboratory studies. * Autonomic neuropathy as defined by the Toronto Diabetic Neuropathy Expert Group 2010/11 consensus criteria. Subjects with be entered into the study if they have (1) increased symptoms of autonomic neuropathy based on an increase in the number of symptoms (\>3) OR impact score (\>7) in the validated SAS OR (2) at least two abnormalities on autonomic testing. The autonomic testing includes: (a) heart rate variability (E:I ratio and heart rate range-HRR), (b) Valsalva ratio, (c) Valsalva beat to beat blood pressure variation, (d) 30:15 ratio, (e) tilt table testing, and (f) QSART values. * Age 30 (to exclude patients with type 1 diabetes) to 80 years inclusive * Medically stable at the time of enrollment. * 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 take an alternative medication to coumadin when undergoing a skin biopsy. Exclusion Criteria: * Pregnant women, prisoners, institutionalized subjects and other at risk subjects will not be included in this study. * Neuropathy due to factors other than impaired glucose regulation based on careful clinical and laboratory evaluation by the physician. * Current severe medical conditions that are active on the day of screening that would affect the patient's ability to participate in or complete the study. * Autonomic neuropathy that is so severe that it would limit the patient's ability to participate in the study interventions.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
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Other studies related to the condition(s) this trial covers.
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