Diabetic NeuropathyNIRNCT01707979
NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes
An observational study of Diabetic Neuropathy, run by Lise Tarnow at 1 site in Denmark.
Trial summary
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance. Read more about this study
- Who is it for?
- Ages 35 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathy
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Oct 2012
- 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 35 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications
Who may be able to join
- men with type 1 diabetes (WHO criteria)
- age 35-50 years
- duration of diabetes > 10 years
Who cannot join
- P-creatinine> 120 micromol/l
- other acute or chronic disease, or type of treatment that makes the patient unsuitable to participate, valuated by the investigator
- non intact skin on the measuring spots
- the patient is unable to understand the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NIR (Near Infrared)- Spectroscopy and Multifrequent Impedance Spectroscopy on the Skin to Detection of Sensory and Autonomic Neuropathy Among Patients With Type 1 Diabetes
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.
Read the detailed description
The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy.
The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.
- Conditions
- Diabetic Neuropathy
- Keywords
- Near infrared light, Diabetic neuropathy, Sensory neuropathy, Autonomic neuropathy, Vagus, Sudomotor function, Monofilament, Impedance
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic neuropathy | Male participants, type1 diabetic with diabetic neuropathy | |
| Diabetes without neuropathy | Male participants, type1 diabetic without diabetic neuropathy | |
| Non diabetic control | Male participants, control group non diabetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
near infrared spectroscopy
Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe
Measured: one time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lise Tarnow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lise Tarnow, Steno Diabetes Center Copenhagen
- Investigators
- Lise Tarnow, Professor, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707979
- Sponsor's protocol ID
- NIR
- Acronym
- NIR
- Status last verified
- Oct 2012
- First submitted
- 25 Sep 2012
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIR (Near Infrared)- Spectroscopy and Multifrequent Impedance Spectroscopy on the Skin to Detection of Sensory and Autonomic Neuropathy Among Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01707979
- Acronym / sponsor ID
- NIR / NIR
- Conditions
- Diabetic Neuropathy
- Keywords
- Near infrared light, Diabetic neuropathy, Sensory neuropathy, Autonomic neuropathy, Vagus, Sudomotor function, Monofilament, Impedance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lise TarnowUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Oct 2012 (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.
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.
Detailed description
The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy.
The DDD-probe is put directly on the skin and is measuring by the use of light and impedance.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic neuropathy | – | –Male participants, type1 diabetic with diabetic neuropathy |
| Diabetes without neuropathy | – | –Male participants, type1 diabetic without diabetic neuropathy |
| Non diabetic control | – | –Male participants, control group non diabetic |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications
Key inclusion criteria (3 listed)
- men with type 1 diabetes (WHO criteria)
- age 35-50 years
- duration of diabetes > 10 years
Key exclusion criteria (4 listed)
- P-creatinine> 120 micromol/l
- other acute or chronic disease, or type of treatment that makes the patient unsuitable to participate, valuated by the investigator
- non intact skin on the measuring spots
- the patient is unable to understand the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
near infrared spectroscopy
Time frame: one time
Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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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.
Lise Tarnow, Professor principal investigator
Steno Diabetes Center Copenhagen
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 Diabetic Neuropathy, run by Lise Tarnow at 1 site in Denmark.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 16 Oct 2012. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
near infrared spectroscopy (time frame: one time). 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 16 Oct 2012.