Intra-epidermal Nerve Fiber Densities (IENFDs): A Study of Olmsted County Inhabitants and Surrounding Area, Including Normal Subjects, Patients with Neuropathy or Impaired Glucose and Newly Diagnosed Diabetics

Overview

About this study

This is a study of nerve fibers to the skin of your body, counts of which are used to determine disease of nerves called "small nerve fiber neuropathy." Counting nerve fibers of a small sample of skin gives an indication of whether the numbers of these fibers are normal or decreased. A decreased number is an indication of abnormality, that is, of disease of small nerve fibers (small fiber sensory neuropathy). This study, therefore, may be useful in diagnosing small fiber sensory neuropathy in people who have diabetes mellitus and other diseases. Skin samples will be used to determine what is normal for age, gender, and other physical features.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Patients who have previously participated in the RDNS-HS cohort studies.
    1. These patients are without neurologic disease or diseases predisposing to peripheral neuropathy.
  2. Patients who have a clinical diagnosis of neuropathy.
  3. RDNS-GI patients with IGT (2 hr PG > 140-199 mg/dl) two hours after 75 gm glucose load but do not have DM by IFG(>126mg/dl and A1C >6.5%) and have not been diagnosed or treated for DM.
  4. Newly diagnosed diabetic patients (determined by the 2 hour glucose tolerance test) will be allowed to continue in the study.

Exclusion Criteria:

  1. RDNS-HSs having neurologic disease or diseases predisposing to peripheral neuropathy. 
    1. RDNS-HS having an FPG of ≥ 110 mg/dl and patient with A1C values >6%. RDNS-HS with summated 5 nerve conductions nd values >95%.  
  2. No exclusion criteria for clinically diagnosed neuropathy cases.  
  3. RDNS-GI patients will be included as they could possibly fall within the healthy subject, GI or DM category.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Peter Dyck, M.D.

Closed for enrollment

Contact information:

Karen Lodermeier

(507)538-6997

Lodermeier.Karen@mayo.edu

More information

Publications

Publications are currently not available