Neurogenic Inflammation in Diabetes

NCT ID: NCT01370837

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-01-31

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.

Conditions

Diabetes Mellitus; Polyneuropathies; Arthropathy, Neurogenic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy controls

Group Type: EXPERIMENTAL

Intracutaneous injection of Candida albicans antigen.

Intervention Type: OTHER

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

Temperature measurement.

Intervention Type: 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.

Diabetes

Patients with diabetes mellitus without polyneuropathy.

Group Type: EXPERIMENTAL

Intracutaneous injection of Candida albicans antigen.

Intervention Type: OTHER

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

Temperature measurement.

Intervention Type: 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.

Polyneuropathy

Patients with diabetes and polyneuropathy.

Group Type: EXPERIMENTAL

Intracutaneous injection of Candida albicans antigen.

Intervention Type: OTHER

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

Temperature measurement.

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dutch Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kristy Pickwell

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicolaas Schaper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 31557355 (View on PubMed)

Other Identifiers

METC 11-2-044

Identifier Type: -

Identifier Source: org_study_id