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


Lead sponsor: AHEPA University Hospital

Source AHEPA University Hospital
Brief 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

Overall Status Unknown status
Start Date June 2011
Primary Completion Date June 2013
Study Type Observational
Primary Outcome
Measure Time Frame
number of participants with abnormal results 1 day (at time of examination)
Enrollment 100

Intervention type: Radiation

Intervention name: metaiodobenzylguanidine scintigraphy

Arm group label: Patients with type 1 diabetes mellitus


Sampling method: Non-Probability Sample


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

Gender: All

Minimum age: 20 Years

Maximum age: 49 Years

Healthy volunteers: Accepts Healthy Volunteers

facility AHEPA hospital, First Propedeutic clinic of internal medicine
Location Countries


Verification Date

March 2013

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: AHEPA University Hospital

Investigator full name: Zantidis Anestis

Investigator title: MD

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Patients with type 1 diabetes mellitus

Description: Metaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring

Arm group label: Healthy controls

Description: Autonomic function tests, Pupillometry, Holter monitoring

Study Design Info

Observational model: Case Control

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov