Changes in Skin Innervation of Neurologically Asymptomatic Type 2 Diabetic Patients: the Correlation With the Diabetic Parameters and Neurotrophins.

NCT00155142 | Unknown

• 1 other identifier: 9361701104
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To address the following issues: (1) the course of small nerve fiber degeneration in type 2 diabetic patients, especially in asymptomatic patients; (2) the influence of blood sugar control on development of the small fiber degeneration; (3) the correlation of skin innervation with sensory thresholds, autonomic tests and parameters of nerve conduction studies; and (4) the role of neurotrophins in diabetic neuropathy, we will perform skin biopsy with quantification of IENF in type 2 diabetic patient without neurological symptoms. The investigations all include clinical evaluation, electrophysiological studies, quantitative sensory test and enzyme linked immunosorbent assay of neurotrophins. The analysis of skin innervation with diabetic parameters will give important insights into the mechanism, prevention and management of small fiber neuropathy in neurologically asymptomatic type 2 diabetic patients, and also therapeutic strategies for diabetic neuropathy.

Conditions

Diabetes Mellitus

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) patients fulfilling the diagnosis of type 2 diabetes mellitus19 and receiving oral hyperglycemic agent or insulin treatment with regular follow-up at outpatient clinics, (2) neurologically asymptomatic, i.e. absence of subjective motor or sensory symptom, and absence of motor or sensory sign on neurological examinations, (3) absence of renal impairment or other systemic disease, (4) absence of bleeding tendency, obvious limb edema, poor cardiopulmonary function, acute symptoms of poor diabetic control or any other contraindication for skin biopsy.

You may not qualify if:

• Use of anti-coagulant; any causes with bleeding tendency; moderate to severe limb edema; history of poor wound healing; poor hygiene and poor care patients; uremia under dialysis.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Anatomy and Cell Biology, National Taiwan University College of Medicine

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sung-Tsang Hsieh, PhD

  Department of Anatomy and Cell Biology, National Taiwan University College of Medicine; Department of Neurology, National Taiwan University Hospital.

  STUDY DIRECTOR

Central Study Contacts

Sung-Tsang Hsieh, PhD

CONTACT

886-2-23123456; sthsieh@ha.mc.ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2004
• Last Updated: November 28, 2005

Record last verified: 2004-09

Locations

TW (1)