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Trial record 37 of 228 for:    yeast

Neurogenic Inflammation in Diabetes

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ClinicalTrials.gov Identifier: NCT01370837
Recruitment Status : Completed
First Posted : June 10, 2011
Results First Posted : April 10, 2015
Last Update Posted : May 6, 2015
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by (Responsible Party):
Kristy Pickwell, Maastricht University Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Diabetes Mellitus
Polyneuropathies
Arthropathy, Neurogenic
Interventions Other: Intracutaneous injection of Candida albicans antigen.
Other: Temperature measurement.
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Healthy Controls Diabetes Polyneuropathy
Hide Arm/Group Description

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes mellitus without polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes and polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Period Title: Overall Study
Started 12 12 17
Completed 12 12 17
Not Completed 0 0 0
Arm/Group Title Healthy Controls Diabetes Polyneuropathy Total
Hide Arm/Group Description

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes mellitus without polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes and polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Total of all reporting groups
Overall Number of Baseline Participants 12 12 17 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 17 participants 41 participants
59  (8.8) 65  (6.7) 66  (5.2) 64  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 17 participants 41 participants
Female
4
  33.3%
2
  16.7%
3
  17.6%
9
  22.0%
Male
8
  66.7%
10
  83.3%
14
  82.4%
32
  78.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 12 participants 12 participants 17 participants 41 participants
12 12 17 41
1.Primary Outcome
Title Induration Size as a Response to Intracutaneous Candida Albicans.
Hide Description [Not Specified]
Time Frame 48 hours after injection.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls Diabetes Polyneuropathy
Hide Arm/Group Description:

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes mellitus without polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes and polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Overall Number of Participants Analyzed 12 12 17
Median (95% Confidence Interval)
Unit of Measure: millimeters
Arm
4
(1 to 13.5)
6
(1.5 to 11)
5
(2 to 6)
Foot
4
(0 to 9)
2
(0 to 11.5)
0
(0 to 1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Healthy Controls, Diabetes
Comments Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Healthy Controls, Diabetes
Comments Foot
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Diabetes, Polyneuropathy
Comments Arm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Diabetes, Polyneuropathy
Comments Foot
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Healthy Controls
Comments Arm vs foot
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Diabetes
Comments Arm vs foot
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Polyneuropathy
Comments Arm vs foot
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Controls Diabetes Polyneuropathy
Hide Arm/Group Description

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes mellitus without polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

Patients with diabetes and polyneuropathy.

Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.

Temperature measurement.: 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.

All-Cause Mortality
Healthy Controls Diabetes Polyneuropathy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Controls Diabetes Polyneuropathy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   1/17 (5.88%) 
Skin and subcutaneous tissue disorders       
Allergic reaction to Candida antigen  0/12 (0.00%)  0/12 (0.00%)  1/17 (5.88%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Controls Diabetes Polyneuropathy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/17 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristy Pickwell
Organization: Maastricht University Medical Center
Phone: +31433877019
EMail: k.pickwell@mumc.nl
Layout table for additonal information
Responsible Party: Kristy Pickwell, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01370837     History of Changes
Other Study ID Numbers: METC 11-2-044
First Submitted: June 7, 2011
First Posted: June 10, 2011
Results First Submitted: March 30, 2015
Results First Posted: April 10, 2015
Last Update Posted: May 6, 2015