Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo treatment | Placebo Comparator | Placebo solution will be slowly titrated to maximum tolerable dose in order to minimize potential side-effects, hence treatment will follow: First and second week: 0.6 mg/day; Third and fourth week: 1.2 mg/day and Fifth and to sixth week: 1.8 mg/day. |
|
| Liraglutide treatment | Active Comparator | Liraglutide will be slowly titrated to maximum tolerable dose in order to minimize potential side-effects, hence treatment will follow: First and second week: 0.6 mg/day; Third and fourth week: 1.2 mg/day and Fifth and to sixth week: 1.8 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo treatment | Drug | Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RIII withdrawal reflex activity (using standard electromyography) | After 6 months of treatment with Liraglutide | |
| Evoked brain potentials (using standard electroencephalographic brain imaging). | After 6 months of treatment with Liraglutide |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability/ alterations in simpatico-vagal balance (24 h Holter monitoring) | After 6 months of treatment with Liraglutide | |
| Resting brain activity (spectral analysis of resting brain activity) | After 6 months of treatment with Liraglutide |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C | After 6 months of treatment with Liraglutide | |
| Biochemical lipid profile | After 6 months of treatment with Liraglutide | |
| Heart rate and blood pressure |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Asbjørn M. Drewes, Professor | Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital | Aalborg | Jutland | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34918951 | Derived | Arendt Nielsen T, Sega R, Uggerhoj Andersen C, Vorum H, Drewes AM, Jakobsen PE, Brock B, Brock C. Liraglutide Treatment Does Not Induce Changes in the Peripapillary Retinal Nerve Fiber Layer Thickness in Patients with Diabetic Retinopathy. J Ocul Pharmacol Ther. 2022 Jan-Feb;38(1):114-121. doi: 10.1089/jop.2021.0055. Epub 2021 Dec 16. | |
| 32571684 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Liraglutide treatment | Drug | Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose. |
|
| Microstructural brain neurodegeneration (assessed by diffuse tensor imaging) | After 6 months of treatment with Liraglutide |
| Variety in day/night blood pressure | After 6 months of treatment with Liraglutide |
| Gut transit assessed by SmartPill (pH, pressure and transit in stomach, small and large intestine) | After 6 months of treatment with Liraglutide |
| Quantitive sensory testing of pressure algometry in muscle | After 6 months of treatment with Liraglutide |
| Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec) | 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. | After 6 months of treatment with Liraglutide |
| Metabolic risk factors expressed as adipokines (adiponectin, leptin, resistin) and inflammatory cell markers | 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)) | After 6 months of treatment with Liraglutide |
| OCT | After 6 months of treatment with Liraglutide |
| After 6 months of treatment with Liraglutide |
| Weight/body mass index | After 6 months of treatment with Liraglutide |
| Nissen TD, Meldgaard T, Nedergaard RW, Juhl AH, Jakobsen PE, Karmisholt J, Drewes AM, Brock B, Brock C. Peripheral, synaptic and central neuronal transmission is affected in type 1 diabetes. J Diabetes Complications. 2020 Sep;34(9):107614. doi: 10.1016/j.jdiacomp.2020.107614. Epub 2020 May 8. |
| 32501945 | Derived | Nedergaard RB, Nissen TD, Morch CD, Meldgaard T, Juhl AH, Jakobsen PE, Karmisholt J, Brock B, Drewes AM, Brock C. Diabetic Neuropathy Influences Control of Spinal Mechanisms. J Clin Neurophysiol. 2021 Jul 1;38(4):299-305. doi: 10.1097/WNP.0000000000000691. |
| 31338868 | Derived | Brock C, Hansen CS, Karmisholt J, Moller HJ, Juhl A, Farmer AD, Drewes AM, Riahi S, Lervang HH, Jakobsen PE, Brock B. Liraglutide treatment reduced interleukin-6 in adults with type 1 diabetes but did not improve established autonomic or polyneuropathy. Br J Clin Pharmacol. 2019 Nov;85(11):2512-2523. doi: 10.1111/bcp.14063. Epub 2019 Aug 30. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |