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Completed

NCT Number: NCT01707979

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

The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

35 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. near infrared spectroscopy

    Time frame: one time

    Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe

Sponsors and collaborators

Lead sponsor

Lise Tarnow

Other

Registry information

Official study 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

Acronym: NIR

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 16, 2012
Registry last updated
Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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