- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01707979
NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes (NIR)
October 15, 2012 updated by: Lise Tarnow
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
30
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
-
-
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Gentofte, Denmark, 2820
- Steno Diabetes center
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-
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
35 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications
Description
Inclusion Criteria:
- men with type 1 diabetes (WHO criteria)
- age 35-50 years
- duration of diabetes > 10 years
Exclusion Criteria:
- 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
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
near infrared spectroscopy
Time Frame: one time
|
Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe
|
one time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lise Tarnow, Professor, Steno Diabetes Center Copenhagen
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
September 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
September 25, 2012
First Submitted That Met QC Criteria
October 15, 2012
First Posted (Estimate)
October 16, 2012
Study Record Updates
Last Update Posted (Estimate)
October 16, 2012
Last Update Submitted That Met QC Criteria
October 15, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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