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

Diabetic Neuropathy Clinical Trial

— NIR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707979
• Other study ID #: NIR
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: October 15, 2012
• Start date: September 2012
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Steno Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics CommitteeDenmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Medicines Agency
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 50 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center	Gentofte

Sponsors (1)

Lead Sponsor	Collaborator
Lise Tarnow

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	near infrared spectroscopy	Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe	one time	No