Status:
ACTIVE_NOT_RECRUITING
Improving Autonomic Function and Balance in Diabetic Neuropathy
Lead Sponsor:
VA Office of Research and Development
Conditions:
Diabetes
Neuropathy
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
Type 2 diabetes (DM2) affects nearly 20 million people in the United States while impaired glucose regulation (IGR), which includes impaired glucose tolerance (IGT), impaired fasting glucose (IFG), an...
Detailed Description
Study on hold due to COVID-19 In this proposed study, investigators will determine if an intense, individually tailored, carefully monitored, Diet, Physical Activity and Balance Enhancement Program (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01864460
Start Date
November 14 2013
End Date
November 30 2026
Last Update
September 1 2023
Active Locations (1)
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1
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201