NCT01707979

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2012

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

1 month

First QC Date

September 25, 2012

Last Update Submit

October 15, 2012

Conditions

Diabetic Neuropathy

Keywords

Near infrared lightDiabetic neuropathySensory neuropathyAutonomic neuropathyVagusSudomotor functionMonofilamentImpedance

Outcome Measures

Primary Outcomes (1)

  • near infrared spectroscopy

    Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe

    one time

Study Arms (3)

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

Eligibility Criteria

Age35 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • men with type 1 diabetes (WHO criteria)
  • age 35-50 years
  • duration of diabetes \> 10 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Lise Tarnow, Professor

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Chief Physician

Study Record Dates

First Submitted

September 25, 2012

First Posted

October 16, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

DK(1)