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

AHEPA University Hospital

Status: Unknown

Conditions: Autonomic Neuropathy

Treatments: Radiation: metaiodobenzylguanidine scintigraphy

Study type: Observational

Funder types: Other

Identifiers

NCT01822431

A-Z0001

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Patients with type 1 diabetes mellitus

Description:

Metaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring

Treatment:

Radiation: metaiodobenzylguanidine scintigraphy

Healthy controls

Description:

Autonomic function tests, Pupillometry, Holter monitoring