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

NCT ID: NCT01707979

Last Updated: 2012-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-10-31

Brief Summary

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The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance.

Detailed Description

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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.

Conditions

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Diabetic Neuropathy

Keywords

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Near infrared light Diabetic neuropathy Sensory neuropathy Autonomic neuropathy Vagus Sudomotor function Monofilament Impedance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetic neuropathy

Male participants, type1 diabetic with diabetic neuropathy

No interventions assigned to this group

Diabetes without neuropathy

Male participants, type1 diabetic without diabetic neuropathy

No interventions assigned to this group

Non diabetic control

Male participants, control group non diabetic

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lise Tarnow

OTHER

Sponsor Role lead

Responsible Party

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Lise Tarnow

Professor, Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lise Tarnow, Professor

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

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Steno Diabetes Center

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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NIR

Identifier Type: -

Identifier Source: org_study_id