About this trial
Aim of the work:
To evaluate efficacy and safety of Piracetam in Diabetic patients with peripheral neuropathy.
Scientific background:
Diabetes mellitus (DM) is known to precipitate various neurologic complications, with diabetic neuropathy (DN) emerging as a significant microvascular consequence affecting both type 1 and type 2 diabetes mellitus (T2DM) patients. Notably, diabetic neuropathy can manifest even at the onset of type 2 diabetes mellitus. Peripheral neuropathy stands as the most common subtype of diabetic neuropathy, impacting nearly half of all individuals with diabetes over their lifetimes, as per recent guidelines. The development of diabetic neuropathy (DN) involves various metabolic and cellular processes, including inflammation and oxidative stress. Inflammation, characterized by cytokines and inflammatory cells, plays a role in diabetic neuropathy progression. Reactive oxygen species (ROS) contribute significantly, with low levels of antioxidants exacerbating the condition. Accumulation of advanced glycation end products (AGEs) further damages nerves. diabetic neuropathy leads to significant pain and discomfort for patients, yet current treatments often fall short of expectations. Improving treatment strategies is crucial to relieve suffering and improve the well-being of those affected by diabetic neuropathy. Piracetam shows promise in managing diabetic neuropathy (DN) based on both preclinical and clinical studies. It may enhance central nervous system function by influencing neurotransmitter release, potentially alleviating diabetic neuropathy symptoms. Additionally, piracetam's neuroprotective properties could shield nerve cells from oxidative stress and inflammation, which are key contributors to diabetic neuropathy nerve damage.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (>the age of 18).
Established diagnosis of type 2 Diabetes Mellitus.
Patients receiving insulin therapy.
Stable regimen for at least 3 months prior to inclusion in the study
Disqualifiers
Patients with inadequate hepatic function Alanine aminotransferase, Aspartate aminotransferase (ALT, AST > or equal to 3 times upper normal limit).
Patients with myopathy, epilepsy, malignancy, unstable psychiatric illness, bleeding tendency, or peripheral vascular diseases.
Patients with an estimated Glomerular Filtration Rate (GFR) Less than 45 ml/min and albumin/creatinine ratio or urea to creatinine >30.
Patients with any conditions that could confound pain assessment (for ex: other severe pain or skin conditions in the area affected by neuropathy.
Trial design
Parallel
Treatments tested in this trial
Piracetam
Drug800mg oral tablet of Piracetam three times every day for 3 months
Placebo
Drugstarch tablet
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of efficacy:1. Measurment of McGill Pain Scale:
Neuropathic pain severity will be assessed at baseline and every 4 weeks during the whole study duration using The Short-Form McGill Pain Questionnaire (SF-MPQ).The SF-MPQ is a concise assessment tool consisting of 15 items that evaluate both the sensory and affective dimensions of pain experience, Participants rate the intensity of each item on a four-point scale ranging from 0 (none) to 3 (severe). By summing the intensity values for the corresponding descriptors, sensory (11 items), affective (4 items), and total (15 items) pain scores can be obtained.
Evaluation of efficacy: 2. Assessment of the vibratory sensation using Michigan neuropathy screening instrument
Assessment of patients' vibratory sensation will be performed using Michigan Neuropathy screening Instrument , The MNSI consists of two parts, one of them a questionnaire for the patient, a higher score (with a maximum of 13 points) indicates a greater presence of neuropathic symptoms, and the second part is done by the examiner and contains physical examination tests, A high score on the questionnaire, reduced or absent vibration sense, reduced or absent ankle reflexes, and reduced or absent sensation on the monofilament test are all indicative of neuropathic symptoms, suggesting the presence of diabetic neuropathy. Patients who score above 2 points on a 10-point scale in the clinical section of the MNSI are considered to have neuropathic symptoms.
Evaluation of efficacy:3. Assessment of EQ-5D-5L Score:
Assessment of patients' Quality of life will be performed using EQ-5D-5L questionnaire, The EQ-5D-5L consists of a concise descriptive system questionnaire and a visual analog scale (EQ VAS),The questionnaire captures a straightforward profile of an individual's health state, while the EQ VAS offers an alternative approach to gauge an individual's self-rated overall current health, The updated version of the EQ-5D, known as the EQ-5D-5L, introduces five levels of severity for each of the existing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Within the EQ-5D-5L descriptive system, there are five dimensions, and each dimension encompasses five response levels, ranging from 1 which indicates absence of problems to 5 which indicates Inability to perform/extreme problems.
Evaluation of efficacy: 4. Assessment of Pittsburgh sleep quality index Score:
Sleep disturbance will be assessed, The Pittsburgh sleep quality index questionnaire about usual sleeping habits for the past month only. These questions are consolidated to create seven distinct "component" scores, each with a scoring range of 0-3 points. It is important to note that a score of "0" indicates the absence of any difficulties, while a score of "3" signifies the presence of severe difficulties. Subsequently, the seven component scores are combined to generate a single "global" score, spanning from 0 to 21 points. Within this framework, a score of "0" indicates the absence of any difficulties across all domains, while a score of "21" signifies the presence of severe difficulties in all areas.
Locations
Sponsors and contacts
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Ain Shams University
Lead sponsor
King Salman International university
Sponsor institution
King Salman International university
Collaborator
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