Autonomic NeuropathyNCT01822431
A Comparison Between Pupillometry, Heart Rate Variability and Metaiodobenzylguanidine Scintigraphy for the Diagnosis of Early Diabetic Autonomic Neuropathy in Type 1 Diabetes
An observational study of Autonomic Neuropathy, run by AHEPA University Hospital at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Neuropathy
- What is being tested?
- metaiodobenzylguanidine scintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients: outpatient diabetes clinic of AHEPA university hospital Controls: residents of Thessaloniki area
Who may be able to join
- Type 1 diabetes mellitus
Who cannot join
- 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
Show all 9Show fewer
- Thyroid disease
- Vitamin B insufficiency
- Other possible cause for autonomic failure
Trial locations and contacts
1 site in 1 country.
Greece1 site
AHEPA hospital, First Propedeutic clinic of internal medicine
Thessaloniki, Thessaloniki, 54636
About this study
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
- Conditions
- Autonomic Neuropathy
- Being tested
- metaiodobenzylguanidine scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metaiodobenzylguanidine scintigraphyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 1 diabetes mellitus | Metaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring Receives: Radiation: metaiodobenzylguanidine scintigraphy | |
| Healthy controls | Autonomic function tests, Pupillometry, Holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with abnormal results
Measured: 1 day (at time of examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJun 2011
- Primary completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zantidis Anestis, AHEPA University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822431
- Sponsor's protocol ID
- A-Z0001
- Status last verified
- Mar 2013
- First submitted
- 28 Mar 2013
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Pupillometry, Heart Rate Variability and Metaiodobenzylguanidine Scintigraphy for the Diagnosis of Early Diabetic Autonomic Neuropathy in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01822431
- Acronym / sponsor ID
- A-Z0001
- Conditions
- Autonomic Neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (estimated)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 1 diabetes mellitus | – | Radiation: metaiodobenzylguanidine scintigraphyMetaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring |
| Healthy controls | – | –Autonomic function tests, Pupillometry, Holter monitoring |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients: outpatient diabetes clinic of AHEPA university hospital Controls: residents of Thessaloniki area
Key inclusion criteria (1 listed)
- Type 1 diabetes mellitus
Key exclusion criteria (9 listed)
- Type 2 diabetes mellitus
- Severe cardiac autonomic neuropathy
- Medications other than insulin
- Ocular disease other than refractive eye disorders
- History of neurologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metaiodobenzylguanidine scintigraphy | Radiation | Patients with type 1 diabetes mellitus |
Primary outcome
number of participants with abnormal results
Time frame: 1 day (at time of examination)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Neuropathy, run by AHEPA University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with abnormal results (time frame: 1 day (at time of examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013.