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

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ClinicalTrials.gov Identifier: NCT01707979
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.

Condition or disease
Diabetic Neuropathy

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
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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
Study Start Date : September 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. near infrared spectroscopy [ Time Frame: one time ]
    Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707979


Locations
Denmark
Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Lise Tarnow
Investigators
Principal Investigator: Lise Tarnow, Professor Steno Diabetes Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Lise Tarnow, Professor, Chief Physician, Steno Diabetes Center
ClinicalTrials.gov Identifier: NCT01707979     History of Changes
Other Study ID Numbers: NIR
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Lise Tarnow, Steno Diabetes Center:
Near infrared light
Diabetic neuropathy
Sensory neuropathy
Autonomic neuropathy
 Vagus
Sudomotor function
Monofilament
Impedance

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetic Neuropathies
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications