A Comparison Between Pupillometry, Heart Rate Variability and Metaiodobenzylguanidine Scintigraphy for the Diagnosis of Early Diabetic Autonomic Neuropathy in Type 1 Diabetes
1 other identifier
observational
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 28, 2013
CompletedFirst Posted
Study publicly available on registry
April 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedApril 2, 2013
March 1, 2013
2 years
March 28, 2013
April 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
number of participants with abnormal results
1 day (at time of examination)
Study Arms (2)
Patients with type 1 diabetes mellitus
Metaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring
Healthy controls
Autonomic function tests, Pupillometry, Holter monitoring
Interventions
Eligibility Criteria
Patients: outpatient diabetes clinic of AHEPA university hospital Controls: residents of Thessaloniki area
You may qualify if:
- Type 1 diabetes mellitus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AHEPA hospital, First Propedeutic clinic of internal medicine
Thessaloniki, Thessaloniki, 54636, Greece
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 28, 2013
First Posted
April 2, 2013
Study Start
June 1, 2011
Primary Completion
June 1, 2013
Last Updated
April 2, 2013
Record last verified: 2013-03