Neurogenic Inflammation in Diabetes

Maastricht University Medical Center41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus Polyneuropathies Arthropathy, Neurogenic

Interventions

Intracutaneous injection of Candida albicans antigen.OTHER

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

Temperature measurement.OTHER

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Neurogenic Inflammation in Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes