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The Effect of Piracetam on Diabetic Peripheral Neuropathy Patients

NCT06479629 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-28

No results posted yet for this study

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.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DRUG

Piracetam

800mg oral tablet of Piracetam three times every day for 3 months

DRUG

Placebo

starch tablet

Sponsors & Collaborators

  • King Salman International university

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2025-11-01
Completion
2025-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06479629 on ClinicalTrials.gov