Clinical Trial

The Effect of Piracetam on Diabetic Peripheral Neuropathy Patients

Study acronym: DPN
Not Yet Recruiting Phase 4
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Record status
This record was last updated January 28, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-23; most recent amendment 2025-01-27.
Trial Details
NCT Number NCT06479629
Lead Sponsor Ain Shams University
Collaborators: King Salman International university
Conditions Diabetic Peripheral Neuropathy
Enrollment 60 participants
Start Date 2025-02-10
Primary Completion 2025-11-01 (estimated)
Study Completion 2025-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-28