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

April 1, 2013 updated by: Zantidis Anestis, AHEPA University Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloniki, Greece, 54636
        • AHEPA hospital, First Propedeutic clinic of internal medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients: outpatient diabetes clinic of AHEPA university hospital Controls: residents of Thessaloniki area

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with type 1 diabetes mellitus
Metaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring
Radiation: metaiodobenzylguanidine scintigraphy
Healthy controls
Autonomic function tests, Pupillometry, Holter monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of participants with abnormal results
Time Frame: 1 day (at time of examination)
1 day (at time of examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (ESTIMATE)

April 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 2, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-Z0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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