The purpose of this trial is to explore whether liraglutide has a long term effect on clinical symptoms and biomarkers in patients with diabetic neuropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.
Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.
Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
Aalborg, Jutland, Denmark
RIII withdrawal reflex activity (using standard electromyography)
Time frame: After 6 months of treatment with Liraglutide
Evoked brain potentials (using standard electroencephalographic brain imaging).
Time frame: After 6 months of treatment with Liraglutide
Heart rate variability/ alterations in simpatico-vagal balance (24 h Holter monitoring)
Time frame: After 6 months of treatment with Liraglutide
Resting brain activity (spectral analysis of resting brain activity)
Time frame: After 6 months of treatment with Liraglutide
Microstructural brain neurodegeneration (assessed by diffuse tensor imaging)
Time frame: After 6 months of treatment with Liraglutide
Variety in day/night blood pressure
Time frame: After 6 months of treatment with Liraglutide
Gut transit assessed by SmartPill (pH, pressure and transit in stomach, small and large intestine)
Time frame: After 6 months of treatment with Liraglutide
Quantitive sensory testing of pressure algometry in muscle
Time frame: After 6 months of treatment with Liraglutide
Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec)
Time frame: After 6 months of treatment with Liraglutide
Profile of inflammatory cytokines including IL-beta, TNF-alfa, IL6, MCP-1 and specific markers sCD163, sMR, neopterin and HO-1.
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Time frame: After 6 months of treatment with Liraglutide
Metabolic risk factors expressed as adipokines (adiponectin, leptin, resistin) and inflammatory cell markers
Time frame: After 6 months of treatment with Liraglutide
Self assessed symptomatology (Michigan neuropathy screening tool, Quality of life (SF-36), Pain catastrophizing scale (PCS) and self-assessed gastro-intestinal symptoms (PAGI-SYM))
Time frame: After 6 months of treatment with Liraglutide
OCT
Time frame: After 6 months of treatment with Liraglutide