NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes (NIR)
This study has been completed.
Sponsor:
Lise Tarnow
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
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Purpose
The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.
| Condition |
|---|
|
Diabetic Neuropathy |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Steno Diabetes Center:
Primary Outcome Measures:
- 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
| Enrollment: | 30 |
| Study Start Date: | September 2012 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 50 Years (Adult) |
| Genders 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707979
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Lise Tarnow, Professor, Chief Physician, Steno Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT01707979 History of Changes |
| Other Study ID Numbers: | NIR |
| Study First Received: | September 25, 2012 |
| Last Updated: | October 15, 2012 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Ethics Committee Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Medicines Agency |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 30, 2016