Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479629
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-16
Brief Title:
The Effect of Piracetam on Diabetic Peripheral Neuropathy Patients
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Effect of Piracetam on the Clinical Outcomes of Diabetic Patients With Peripheral Neuropathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPN
Brief 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 piracetams neuroprotective properties could shield nerve cells from oxidative stress and inflammation which are key contributors to diabetic neuropathy nerve damage
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 piracetams neuroprotective properties could shield nerve cells from oxidative stress and inflammation which are key contributors to diabetic neuropathy nerve damage
Detailed Description:
Ninety eligible patients will be randomly assigned to two groups
A Piracetam Group 45 patients receiving standard care plus 800mg Piracetam tablets thrice daily for the study duration and B Control Group 45 patients receiving standard care plus a placebo for 3 months Standard care involves insulin therapy with or without oral hypoglycemics and vitamin B complex supplementation
Baseline assessments will include age weight height sex race baseline pain intensity non-opioid analgesic use diabetes medications overall sleep quality symptom duration medication and medical histories and laboratory tests such as HbA1c and fasting glucose levels These assessments represent the outcomes of the clinical trial
Pain intensity was measured using the McGill Pain Questionnaire Vibratory sensation is assessed through the Michigan Neuropathy Screening Test MNSI
Quality of life was evaluated using the EQ-5D-5L questionnaire Sleeping disturbances related to diabetic neuropathy were measured using the Pittsburgh Sleep Quality Index PSQI
Cognitive function was examined with the Montreal Cognitive Assessment Test MoCA
Serum biomarker levels of Brain-Derived Neurotrophic Factor BDNF measured The safety and tolerability of piracetam were assessed throughout the study These assessments will provide valuable insights into the efficacy and safety of piracetam in managing diabetic neuropathy
A Piracetam Group 45 patients receiving standard care plus 800mg Piracetam tablets thrice daily for the study duration and B Control Group 45 patients receiving standard care plus a placebo for 3 months Standard care involves insulin therapy with or without oral hypoglycemics and vitamin B complex supplementation
Baseline assessments will include age weight height sex race baseline pain intensity non-opioid analgesic use diabetes medications overall sleep quality symptom duration medication and medical histories and laboratory tests such as HbA1c and fasting glucose levels These assessments represent the outcomes of the clinical trial
Pain intensity was measured using the McGill Pain Questionnaire Vibratory sensation is assessed through the Michigan Neuropathy Screening Test MNSI
Quality of life was evaluated using the EQ-5D-5L questionnaire Sleeping disturbances related to diabetic neuropathy were measured using the Pittsburgh Sleep Quality Index PSQI
Cognitive function was examined with the Montreal Cognitive Assessment Test MoCA
Serum biomarker levels of Brain-Derived Neurotrophic Factor BDNF measured The safety and tolerability of piracetam were assessed throughout the study These assessments will provide valuable insights into the efficacy and safety of piracetam in managing diabetic neuropathy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None