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
Qualifiers
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
Treatments tested in this trial
- Piracetam
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Ain Shams University
Lead sponsor
King Salman International university
Sponsor institution
King Salman International university
Collaborator