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NCT01822431 Clinical Trial

A Comparison Between Pupillometry, Heart Rate Variability and Metaiodobenzylguanidine Scintigraphy for the Diagnosis of Early Diabetic Autonomic Neuropathy in Type 1 Diabetes

Autonomic Neuropathy Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01822431
Other study ID # A-Z0001
Secondary ID
Status Enrolling by invitation
Phase N/A
First received March 28, 2013
Last updated April 1, 2013
Start date June 2011

Study information
Verified date March 2013
Source AHEPA University Hospital
Contact n/a
Is FDA regulated No
Health authority Greece: Ethics Committee
Study type Observational

Clinical Trial Summary

This study will examine if one of the following methods: pupillometry, spectral analysis of heart rate variability and metaiodobenzylguanidine scintigraphy, is more capable to detect early diabetic autonomic neuropathy in patients with type 1 diabetes mellitus

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 49 Years
Eligibility Inclusion Criteria:

- Type 1 diabetes mellitus

Exclusion Criteria:

- Type 2 diabetes mellitus

- Severe cardiac autonomic neuropathy

- Medications other than insulin

- Ocular disease other than refractive eye disorders

- History of neurologic disease

- History of cardiovascular disease

- Thyroid disease

- Vitamin B insufficiency

- Other possible cause for autonomic failure

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Radiation:
• metaiodobenzylguanidine scintigraphy

Locations
Country Name City State
Greece AHEPA hospital, First Propedeutic clinic of internal medicine Thessaloniki

Sponsors (1)
Lead Sponsor Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of participants with abnormal results 1 day (at time of examination) No
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