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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetic Nerve Problems

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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:


Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases	Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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