diabetic polyneuropathy
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o Aged 18 years or older o Diagnosed by a neurologist with CIAP[24] based on the following criteria o Presence of symmetrical distal sensory or sensorimotor symptoms such as numbness, pins and needles, tightness, coldness, unsteadiness, muscle cramps, and weakness with onset in the lower limbs, compatible with polyneuropathy o Nerve conduction studies excluding a demyelinating polyneuropathy and confirming large nerve fiber involvement in at least two distinct peripheral nerves o No identifiable cause for the polyneuropathy after thorough history-taking, clinical examination, and extensive laboratory testing including complete blood count, glucose, HbA1c, insulin, renal function, liver enzymes, creatine kinase, C-reactive protein, vitamin B1, vitamin B6, folic acid, vitamin B12, homocystein, cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and thyroid-stimulating hormone o Diagnosed by a physician with DPN based on the following criteria o Diagnosed with Diabetes Mellitus Type 2 based on the NHG standard o Presence of symmetrical distal sensory or sensorimotor symptoms such as numbness, pins and needles, tightness, coldness, unsteadiness, muscle cramps, and weakness with onset in the lower limbs, compatible with polyneuropathy. o A Douleur Neuropathique en 4 (DN4)[25] questionnaire score of 4 or higher o Able and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: - Patients who have other types of pain, which could confound the assessment of the neuropathic pain due to CIAP or DPN. - Patient who received Capsaicin 8% patch treatment in the 3 months before inclusion - Patients with skin conditions in the area affected by the polyneuropathy that could alter sensation. - Patients with major cognitive or psychiatric disorders. - Problems with communication (language, deafness, aphasia etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are pathogenic oligomer hIAPP levels in plasma and skin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary outcome measures are pain and sensory assessments using questionnaire data, QST, intraepidermal nerve fiber (IENF) density, CPM, sublingual and skin HVM, and neuroinflammatory markers in plasma. | — |
Countries
Netherlands
Outcome results
None listed