NIR- and Multifrequent Impedance Spectroscopy on the Skin... | NCT01707979

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

NCT01707979

Sponsor

Lise Tarnow

Status

Completed

Last Update Posted

Oct 16, 2012Estimated

Enrollment

30Actual

Phase

Not provided

Conditions

Diabetic Neuropathy

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Sep 25, 2012

First Submission Date that Met QC Criteria

Oct 15, 2012

First Posted Date

Oct 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2012

Last Update Posted Date

Oct 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
near infrared spectroscopy	Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe	one time

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lise Tarnow, Professor	Steno Diabetes Center Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Steno Diabetes Center		Gentofte Municipality		2820	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003929	Diabetic Neuropathies

Ancestor Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications

Browse Leaves

Not provided

Browse Branches

Not provided