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Neurogenic Inflammation in Diabetes

Primary Purpose

Diabetes Mellitus, Polyneuropathies, Arthropathy, Neurogenic

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intracutaneous injection of Candida albicans antigen.
Temperature measurement.
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with type 2 diabetes with and without polyneuropathy.
  • Patients with type 2 diabetes with a history of Charcot's disease.
  • Healthy controls.
  • Signed informed consent.

Exclusion Criteria:

  • Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication.
  • Renal insufficiency: MDRD creatinin clearance < 30 ml/min.
  • Systemic disease such as vasculitis or rheumatoid arthritis.
  • Malignancy.
  • (Diabetic) foot ulcer.
  • Gout.
  • Bacterial infection of an extremity.
  • Skin condition of the dorsal aspect of the foot or the medial side of the upper arm.
  • Bleeding disorder such as hemophilia.
  • Use of medication for asthma.
  • Impaired immunity such as in HIV/AIDS.
  • Capillary blood glucose < 3 mmol/l or > 20 mmol/l at the time of the study.
  • Peripheral oedema.
  • Vaccination in the two months prior to study inclusion.
  • Chemotherapy or radiation therapy in the twelve months prior to study inclusion.
  • Surgery in the two months prior to study inclusion.
  • Previous adverse reaction to Candida albicans antigen.
  • Acute infection at the time of the study or in the month prior to study inclusion.
  • Transfusion in the two months prior to study inclusion.
  • Use of immunosuppressants in the two months prior to study inclusion.
  • Pregnancy or breastfeeding.

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy controls

Diabetes

Polyneuropathy

Arm Description

Patients with diabetes mellitus without polyneuropathy.

Patients with diabetes and polyneuropathy.

Outcomes

Primary Outcome Measures

Induration Size as a Response to Intracutaneous Candida Albicans.

Secondary Outcome Measures

Full Information

First Posted
June 7, 2011
Last Updated
April 16, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Dutch Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01370837
Brief Title
Neurogenic Inflammation in Diabetes
Official Title
Neurogenic Inflammation in Diabetic Polyneuropathy and Charcot Neuro-osteoarthropathy: Response to Intracutaneous Candida Albicans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Dutch Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Polyneuropathy is a complication of diabetes mellitus which leads to decreased sensation in arms and legs. This in turn can lead to the development of (infected) foot ulcers. Charcot's disease can also be a consequence of polyneuropathy. Patients with Charcot's disease suddenly develop a red, warm and swollen foot, like an infection. Charcot's disease leads to foot fractures. After these fractures have healed, the shape of the foot can be dramatically altered. This altered shape of the foot increases the risk of developing foot ulcers. Nerves are important in regulating the inflammatory response. This study aims to investigate whether the inflammatory response is different in patients with polyneuropathy with and without a history of Charcot's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Polyneuropathies, Arthropathy, Neurogenic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Experimental
Arm Title
Diabetes
Arm Type
Experimental
Arm Description
Patients with diabetes mellitus without polyneuropathy.
Arm Title
Polyneuropathy
Arm Type
Experimental
Arm Description
Patients with diabetes and polyneuropathy.
Intervention Type
Other
Intervention Name(s)
Intracutaneous injection of Candida albicans antigen.
Intervention Description
Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
Intervention Type
Other
Intervention Name(s)
Temperature measurement.
Intervention Description
Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.
Primary Outcome Measure Information:
Title
Induration Size as a Response to Intracutaneous Candida Albicans.
Time Frame
48 hours after injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with type 2 diabetes with and without polyneuropathy. Patients with type 2 diabetes with a history of Charcot's disease. Healthy controls. Signed informed consent. Exclusion Criteria: Peripheral arterial disease: toe pressure < 70 mm Hg and/or transcutaneous oxygen tension < 40 mm Hg and/or claudication. Renal insufficiency: MDRD creatinin clearance < 30 ml/min. Systemic disease such as vasculitis or rheumatoid arthritis. Malignancy. (Diabetic) foot ulcer. Gout. Bacterial infection of an extremity. Skin condition of the dorsal aspect of the foot or the medial side of the upper arm. Bleeding disorder such as hemophilia. Use of medication for asthma. Impaired immunity such as in HIV/AIDS. Capillary blood glucose < 3 mmol/l or > 20 mmol/l at the time of the study. Peripheral oedema. Vaccination in the two months prior to study inclusion. Chemotherapy or radiation therapy in the twelve months prior to study inclusion. Surgery in the two months prior to study inclusion. Previous adverse reaction to Candida albicans antigen. Acute infection at the time of the study or in the month prior to study inclusion. Transfusion in the two months prior to study inclusion. Use of immunosuppressants in the two months prior to study inclusion. Pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaas Schaper, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31557355
Citation
Pickwell K, Geerts M, van Moorsel D, Hilkman D, Kars M, Schaper NC. Regional differences in cell-mediated immunity in people with diabetic peripheral neuropathy. Diabet Med. 2020 Feb;37(2):350-355. doi: 10.1111/dme.14143. Epub 2019 Oct 10.
Results Reference
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Neurogenic Inflammation in Diabetes

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