Clinical trial NCT06479629: The Effect of Piracetam on Diabetic Peripheral Neuropathy Patients
Official title: The Effect of Piracetam on the Clinical Outcomes of Diabetic Patients with Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetes
Peripheral Neuropathy
Piracetam
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: King Salman International university
First posted: 2024-06-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, piracetam's 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.

Eligibility criteria: Inclusion Criteria:

1. Adults (\>the age of 18).
2. Established diagnosis of type 2 Diabetes Mellitus.
3. Patients receiving insulin therapy.
4. Stable regimen for at least 3 months prior to inclusion in the study
5. HbA1C\>7.5%

Exclusion Criteria:

* 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.
* Cognitive or language difficulties that would impair understanding/completion of the assessment instruments.
* Presence of foot ulcers.
* Causes of neuropathy other than diabetes and significant neurological diseases.
* Pregnant and/or breastfeeding women.
* Use anticonvulsants, antidepressants, membrane stabilizers, and opioids.
* Patients with a history of Substance use and alcohol abuse,
* Patients with a history of (cerebral hemorrhage) or at risk of blood diseases.
* Patients allergic to piracetam

Primary outcomes:
measure: Evaluation of efficacy:1. Measurment of McGill Pain Scale:
timeFrame: 3 Months
measure: Evaluation of efficacy: 2. Assessment of the vibratory sensation using Michigan neuropathy screening instrument
timeFrame: 3 Months
measure: Evaluation of efficacy:3. Assessment of EQ-5D-5L Score:
timeFrame: 3 Months
measure: Evaluation of efficacy: 4. Assessment of Pittsburgh sleep quality index Score:
timeFrame: 3 Months
measure: Evaluation of efficacy: 5. Measurment of Montreal Cognitive Assessment Scale
timeFrame: 3 Months
measure: Evaluation of efficacy: 6. Evaluation of serum Brain-derived neurotrophic factor:
timeFrame: 3 Months
measure: 7.Incidence of Adverse Events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: