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

This study has been completed.
Sponsor:
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
History of Changes
  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:

U.S. FDA Resources

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
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
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

No publications provided

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 May 22, 2013