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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01822431
Recruitment Status : Unknown
Verified March 2013 by Zantidis Anestis, AHEPA University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 2, 2013
Last Update Posted : April 2, 2013
Information provided by (Responsible Party):
Zantidis Anestis, 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

Condition or disease Intervention/treatment
Autonomic Neuropathy Radiation: metaiodobenzylguanidine scintigraphy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : June 2011
Estimated Primary Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

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

Primary Outcome Measures :
  1. number of participants with abnormal results [ Time Frame: 1 day (at time of examination) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients: outpatient diabetes clinic of AHEPA university hospital Controls: residents of Thessaloniki area

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01822431

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AHEPA hospital, First Propedeutic clinic of internal medicine
Thessaloniki, Greece, 54636
Sponsors and Collaborators
AHEPA University Hospital

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Responsible Party: Zantidis Anestis, MD, AHEPA University Hospital Identifier: NCT01822431     History of Changes
Other Study ID Numbers: A-Z0001
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Nervous System Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action