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

• Conditions: Autonomic Neuropathy
• Interventions: Radiation: metaiodobenzylguanidine scintigraphy

• Registration Number: NCT01822431
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2013-03
• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-04-01
• Last Update Submitted: 2013-04-01
• Study First Posted: 2013-04-02
• Last Update Posted: 2013-04-02
• Primary Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with type 1 diabetes mellitus	metaiodobenzylguanidine scintigraphy	Metaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring

Primary Outcome Measures

Name	Time	Method
number of participants with abnormal results	1 day (at time of examination)

Trial Locations

Locations (1)

AHEPA hospital, First Propedeutic clinic of internal medicine; 🇬🇷 Thessaloniki, Greece