NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01707979
First received: September 25, 2012
Last updated: October 15, 2012
Last verified: October 2012

September 25, 2012
October 15, 2012
September 2012
October 2012   (final data collection date for primary outcome measure)
near infrared spectroscopy [ Time Frame: one time ] [ Designated as safety issue: No ]
Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe
Same as current
Complete list of historical versions of study NCT01707979 on ClinicalTrials.gov Archive Site
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NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications

Diabetic Neuropathy
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Male
35 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01707979
NIR
Yes
Lise Tarnow, Steno Diabetes Center
Lise Tarnow
Not Provided
Principal Investigator: Lise Tarnow, Professor Steno Diabetes Center
Steno Diabetes Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP