Diabetic Peripheral Neuropathy
Conditions
Brief summary
The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN. Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.
Interventions
DIETARY_SUPPLEMENTLevagen+
Participants will take 1 capsule twice daily with water after food. Each capsule will contain: A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA
OTHERPlacebo
Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\]
Sponsors
Gencor Pacific Limited
RDC Clinical Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, single-blind, placebo-controlled, parallel dose response study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-75 years. * Using prescribed glucose-lowering medications, including oral medications (stable dose for 3 months or more) and/or insulin for diabetes (type 1 or 2). * Scoring12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS). * Able to provide informed consent. * Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period. * Agree to not participate in another clinical trial during the study period. * Able to attend an ACL collection centre.
Exclusion criteria
* Peripheral neuropathy due to causes other than diabetes mellitus (e.g. nutritional deficiencies; hereditary sensory neuropathy; paraneoplastic diseases; advanced liver disease; kidney disease; hypothyroidism; prolonged phenytoin, warfarin or immunosuppressive drug use; active infection \[HIV, Lyme disease, Epstein-Barr virus, Hepatitis C, Shingles, Leprosy\]; autoimmune disease \[Sjogren syndrome, Lupus, Rheumatoid arthritis, Guillain-Barre syndrome\]; trauma / injury; toxins \[heavy metals, chemicals\]; antibiotics; or inflammatory conditions \[vasculitis\]). * Serious illness e.g., paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, or heart conditions, or peripheral vascular disease * Unstable illness e.g., diabetes and thyroid gland dysfunction, hypercholesterolemia * Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years. * Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin * Herbal medicines for pain relief including, but not limited to, medicinal cannabis, willow bark (Salix alba), Boswellia (Boswellia serrata) or turmeric/curcumin (Curcuma longa). * Active smokers, nicotine use or drug (prescription or illegal substances) abuse. * Chronic past and/or current alcohol use (\>14 alcoholic drinks per week) * Females attempting to conceive, pregnant or lactating * Allergic, sensitive or intolerant to any of the ingredients in active or placebo formula. * Difficulty swallowing capsules. * Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month. * Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to the end of the study period in overall severity of neuropathic pain | Baseline to week 12 | Change from baseline to the end of the study period in overall severity of neuropathic pain, as assessed by the Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy (BPI-DPN). This is a self-reported scale, higher scores indicate greater pain and interference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory | Baseline to week 12 | Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory (NPSI). This is a self-administered questionnaire used to evaluate neuropathic pain intensity across 5 categories, namely superficial spontaneous pain, deep spontaneous pain, paroxysmal pain, evoked pain, and dysesthesia / paraesthesia. There are 10 pain descriptors and 2 items related to abnormal sensations. The scale ranges from 0 (no pain at all) to 10 (worst pain imaginable). The total scores of all items are combined to find the total pain intensity |
| Change from baseline to the end of the study period in Safety via Adverse Event reporting | Baseline to week 12 | Change from baseline to the end of the study period in safety via Adverse Event reporting and incident rate ratio between placebo and Levagen+ |
| Change from baseline to the end of the study period in Safety Markers (E/LFT) | Baseline to week 12 | Change from baseline to the end of the study period in safety Markers (E/LFT) via blood test. |
| Change from baseline to the end of the study period in Safety (Vitals - BP) | Baseline to week 12 | Change from baseline to the end of the study period in Safety Markers vital signs (blood pressure) |
| Change from baseline to the end of the study period in Safety (Vitals - heart rate) | Baseline to week 12 | Change from baseline to the end of the study period in Safety Markers vital signs (heart rate) |
| Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep) | Baseline to week 12 | Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep). This is a self-administered 12-item questionnaire that includes a Sleep Problem Index and evaluates 6 dimensions of sleep difficulty, namely: sleep disturbance, sleep adequacy, somnolence, quantity of sleep/optimal sleep, awakening short of breath or with headache, and occurrence of snoring. The Sleep Problem Index summarises information across 9 items and is rated on a scale of 1 (all of the time) to 6 (none of the time). |
| Change from baseline to the end of the study period in Safety Markers (FBC) | Baseline to week 12 | Change from baseline to the end of the study period in safety Markers (FBC - Full Blood Count) via blood test. |
| Change from baseline to the end of the study period in Glycaemic control (HbA1c) | Baseline to week 12 | Change from baseline to the end of the study period in Glycaemic control (HbA1c) |
| Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose) | Baseline to week 12 | Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose) |
| Change from baseline to the end of the study period in Anthropometry (weight) | Baseline to week 12 | Change from baseline to the end of the study period in Anthropometry (weight). |
| Change from baseline to the end of the study period in Anthropometry (height) | Baseline to week 12 | Change from baseline to the end of the study period in Anthropometry (height). |
| Change from baseline to the end of the study period in Anthropometry (BMI) | Baseline to week 12 | Change from baseline to the end of the study period in Anthropometry (BMI). |
| Change from baseline to the end of the study period in use of rescue medication for pain | Baseline to week 12 | Change from baseline to the end of the study period in use of rescue medication for pain. Participants will be allowed to use a rescue medication as needed, with use documented via participant diaries including date, time, dosage, reason for use. Data will be analysed based on total usage, frequency, and the proportion of participants requiring rescue medication. |
| Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21) | Baseline to week 12 | Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21). The DASS-21 is a self-reported questionnaire derived from the original 42-item DASS and is a quantitative measure of distress. It consists of 3 subscales: the depression subscale (DASS-D), anxiety subscale (DASS-A) and stress subscale (DASS-S). Each subscale contains 7 items which are rated on a 4-point severity/frequency scale. The scores for each subscale are calculated by summing the scores for the relevant items. Higher scores indicate greater distress. |
Countries
Australia
Contacts
Primary ContactAmanda Rao
Outcome results
None listed