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
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Condition or disease |
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Diabetic Neuropathy |
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 |
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 |

Group/Cohort |
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Diabetic neuropathy
Male participants, type1 diabetic with diabetic neuropathy
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Diabetes without neuropathy
Male participants, type1 diabetic without diabetic neuropathy
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Non diabetic control
Male participants, control group non diabetic
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- near infrared spectroscopy [ Time Frame: one time ]Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe

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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 |
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

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
Denmark | |
Steno Diabetes Center | |
Gentofte, Denmark, 2820 |
Principal Investigator: | Lise Tarnow, Professor | Steno Diabetes Center |
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 |