## Protocol Section
### Identification Module
**NCT ID:** NCT01707979

**Acronym:** NIR

**Brief Title:** NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes

**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

#### Organization Study ID Info
**ID:** NIR
#### Organization
**Class:** OTHER
**Full Name:** Steno Diabetes Center Copenhagen
### Status Module
#### Completion Date
**Date:** 2012-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-10-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-10-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-10

**Type:** ACTUAL

#### Start Date
**Date:** 2012-09

**Status Verified Date:** 2012-10

#### Study First Post Date
**Date:** 2012-10-16
**Type:** ESTIMATED
**Study First Submit Date:** 2012-09-25
**Study First Submit QC Date:** 2012-10-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Lise Tarnow

#### Responsible Party

**Investigator Affiliation:** Steno Diabetes Center Copenhagen

**Investigator Full Name:** Lise Tarnow

**Investigator Title:** Professor, Chief Physician

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### 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.

### Conditions Module

**Conditions:**

- Diabetic Neuropathy

**Keywords:**

- Near infrared light

- Diabetic neuropathy

- Sensory neuropathy

- Autonomic neuropathy

- Vagus

- Sudomotor function

- Monofilament

- Impedance

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Male participants, type1 diabetic with diabetic neuropathy

**Label:** Diabetic neuropathy

#### Arm Group 2

**Description:** Male participants, type1 diabetic without diabetic neuropathy

**Label:** Diabetes without neuropathy

#### Arm Group 3

**Description:** Male participants, control group non diabetic

**Label:** Non diabetic control

### Outcomes Module

#### Primary Outcomes

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

**Measure:** near infrared spectroscopy

**Time Frame:** one time

### 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

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 35 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** MALE

**Standard Ages:**

- ADULT

**Study Population:** Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gentofte

**Country:** Denmark

**Facility:** Steno Diabetes Center

**Zip:** 2820

#### Overall Officials

**Official 1:**

**Affiliation:** Steno Diabetes Center Copenhagen

**Name:** Lise Tarnow, Professor

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000010523

- Term: Peripheral Nervous System Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000048909

- Term: Diabetes Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: LOW

- As Found: Unknown

- ID: M7124

- Name: Diabetic Neuropathies

- Relevance: HIGH

- As Found: Diabetic Neuropathy

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13432

- Name: Peripheral Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003929

- Term: Diabetic Neuropathies

### Misc Info Module

- Version Holder: 2024-05-24
