Diabetic Peripheral NeuropathyPhase 4DPNNCT06479629
The Effect of Piracetam on Diabetic Peripheral Neuropathy Patients
A Phase 4 study testing Piracetam in people with Diabetic Peripheral Neuropathy, run by Ain Shams University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Piracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2025to 1 Nov 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- HbA1C>7.5%
Who cannot join
- 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.
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Amr Ali Mahfouz, Endocrinology consultant-PhD contact
About this study
Official title: The Effect of Piracetam on the Clinical Outcomes of Diabetic Patients with Peripheral Neuropathy
Aim of the work:
To evaluate efficacy and safety of Piracetam in Diabetic patients with peripheral neuropathy.
Read more
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.
Read the detailed description
Ninety eligible patients will be randomly assigned to two groups:
- 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Piracetam, Placebo
- Keywords
- Diabetes, Peripheral Neuropathy, Piracetam
- Medical subject headings
- Diabetes Mellitus, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiracetamDrug
Also called no other interventions
800mg oral tablet of Piracetam three times every day for 3 months
PlaceboDrug
starch tablet
| Study group | Role | What they receive |
|---|---|---|
| Piracetam Group | Active comparator | receiving standard care according to the institution's protocol, along with 800mg oral tablet of Piracetam three times every day for the whole duration of the study ( 3 Months) Standard care includes insulin therapy with or without oral hypoglycemics and vitamin b complex. Receives: Drug: Piracetam |
| Control Group | Placebo comparator | will receive standard care in accordance with the institution protocol in addition to placebo for 3 months.
Standard care includes insulin therapy with or without oral hypoglycemics and vitamin b complex. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of efficacy:1. Measurment of McGill Pain Scale:
Neuropathic pain severity will be assessed at baseline and every 4 weeks during the whole study duration using The Short-Form McGill Pain Questionnaire (SF-MPQ).The SF-MPQ is a concise assessment tool consisting of 15 items that evaluate both the sensory and affective dimensions of pain experience, Participants rate the intensity of each item on a four-point scale ranging from 0 (none) to 3 (severe). By summing the intensity values for the corresponding descriptors, sensory (11 items), affective (4 items), and total (15 items) pain scores can be obtained.
Measured: 3 Months
Evaluation of efficacy: 2. Assessment of the vibratory sensation using Michigan neuropathy screening instrument
Assessment of patients' vibratory sensation will be performed using Michigan Neuropathy screening Instrument , The MNSI consists of two parts, one of them a questionnaire for the patient, a higher score (with a maximum of 13 points) indicates a greater presence of neuropathic symptoms, and the second part is done by the examiner and contains physical examination tests, A high score on the questionnaire, reduced or absent vibration sense, reduced or absent ankle reflexes, and reduced or absent sensation on the monofilament test are all indicative of neuropathic symptoms, suggesting the presence of diabetic neuropathy. Patients who score above 2 points on a 10-point scale in the clinical section of the MNSI are considered to have neuropathic symptoms.
Measured: 3 Months
Evaluation of efficacy:3. Assessment of EQ-5D-5L Score:
Assessment of patients' Quality of life will be performed using EQ-5D-5L questionnaire, The EQ-5D-5L consists of a concise descriptive system questionnaire and a visual analog scale (EQ VAS),The questionnaire captures a straightforward profile of an individual's health state, while the EQ VAS offers an alternative approach to gauge an individual's self-rated overall current health, The updated version of the EQ-5D, known as the EQ-5D-5L, introduces five levels of severity for each of the existing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Within the EQ-5D-5L descriptive system, there are five dimensions, and each dimension encompasses five response levels, ranging from 1 which indicates absence of problems to 5 which indicates Inability to perform/extreme problems.
Measured: 3 Months
Evaluation of efficacy: 4. Assessment of Pittsburgh sleep quality index Score:
Sleep disturbance will be assessed, The Pittsburgh sleep quality index questionnaire about usual sleeping habits for the past month only. These questions are consolidated to create seven distinct "component" scores, each with a scoring range of 0-3 points. It is important to note that a score of "0" indicates the absence of any difficulties, while a score of "3" signifies the presence of severe difficulties. Subsequently, the seven component scores are combined to generate a single "global" score, spanning from 0 to 21 points. Within this framework, a score of "0" indicates the absence of any difficulties across all domains, while a score of "21" signifies the presence of severe difficulties in all areas.
Measured: 3 Months
Evaluation of efficacy: 5. Measurment of Montreal Cognitive Assessment Scale
Cognitive function will be assessed. The Montreal Cognitive Assessment (MoCA), which is a quick screening assessment used to detect elderly people who have mild cognitive impairment (MCI). It is a single-page examination that may be performed in 10 minutes. This test has a maximum score of 30, with a result of 26 or higher deemed normal. A score of less than 26 without associated functional impairment indicates a diagnosis of mild cognitive impairment. Furthermore, a score of less than 26 combined with functional impairment implies that dementia is in its early stages. It is worth mentioning that an additional point is given whether the individual has completed 12 years of formal education or less.
Measured: 3 Months
Evaluation of efficacy: 6. Evaluation of serum Brain-derived neurotrophic factor:
Blood sample will be withdrawn from each patient at baseline and after 3 months and separated sera will be stored at -80 C till analysis. Serum Brain-derived neurotrophic factor will be assessed for each patient using ELISA kits.
Measured: 3 Months
7.Incidence of Adverse Events
Patients will be educated about any expected side effects and will be required to report any of them.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start10 Feb 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- King Salman International university
- Responsible party
- Principal investigator, Hamsa Amr Mohamed Attia, King Salman International university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479629
- Sponsor's protocol ID
- PHCL 5611
- Acronym
- DPN
- Status last verified
- Jan 2025
- First submitted
- 16 Jun 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Piracetam on the Clinical Outcomes of Diabetic Patients with Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06479629
- Acronym / sponsor ID
- DPN / PHCL 5611
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetes, Peripheral Neuropathy, Piracetam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- King Salman International university
- Study start
- 10 Feb 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piracetam Group | Active comparator | Drug: Piracetamreceiving standard care according to the institution's protocol, along with 800mg oral tablet of Piracetam three times every day for the whole duration of the study ( 3 Months) Standard care includes insulin therapy with or without oral hypoglycemics and vitamin b complex. |
| Control Group | Placebo comparator | Drug: Placebowill receive standard care in accordance with the institution protocol in addition to placebo for 3 months. Standard care includes insulin therapy with or without oral hypoglycemics and vitamin b complex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- HbA1C>7.5%
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiracetamAlso: no other interventions800mg oral tablet of Piracetam three times every day for 3 months | Drug | Piracetam Group |
| Placebostarch tablet | Drug | Control Group |
Primary outcome
Evaluation of efficacy:1. Measurment of McGill Pain Scale:
Time frame: 3 Months
Neuropathic pain severity will be assessed at baseline and every 4 weeks during the whole study duration using The Short-Form McGill Pain Questionnaire (SF-MPQ).The SF-MPQ is a concise assessment tool consisting of 15 items that evaluate both the sensory and affective dimensions of pain experience, Participants rate the intensity of each item on a four-point scale ranging from 0 (none) to 3 (severe). By summing the intensity values for the corresponding descriptors, sensory (11 items), affective (4 items), and total (15 items) pain scores can be obtained.
Evaluation of efficacy: 2. Assessment of the vibratory sensation using Michigan neuropathy screening instrument
Time frame: 3 Months
Assessment of patients' vibratory sensation will be performed using Michigan Neuropathy screening Instrument , The MNSI consists of two parts, one of them a questionnaire for the patient, a higher score (with a maximum of 13 points) indicates a greater presence of neuropathic symptoms, and the second part is done by the examiner and contains physical examination tests, A high score on the questionnaire, reduced or absent vibration sense, reduced or absent ankle reflexes, and reduced or absent sensation on the monofilament test are all indicative of neuropathic symptoms, suggesting the presence of diabetic neuropathy. Patients who score above 2 points on a 10-point scale in the clinical section of the MNSI are considered to have neuropathic symptoms.
Evaluation of efficacy:3. Assessment of EQ-5D-5L Score:
Time frame: 3 Months
Assessment of patients' Quality of life will be performed using EQ-5D-5L questionnaire, The EQ-5D-5L consists of a concise descriptive system questionnaire and a visual analog scale (EQ VAS),The questionnaire captures a straightforward profile of an individual's health state, while the EQ VAS offers an alternative approach to gauge an individual's self-rated overall current health, The updated version of the EQ-5D, known as the EQ-5D-5L, introduces five levels of severity for each of the existing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Within the EQ-5D-5L descriptive system, there are five dimensions, and each dimension encompasses five response levels, ranging from 1 which indicates absence of problems to 5 which indicates Inability to perform/extreme problems.
Evaluation of efficacy: 4. Assessment of Pittsburgh sleep quality index Score:
Time frame: 3 Months
Sleep disturbance will be assessed, The Pittsburgh sleep quality index questionnaire about usual sleeping habits for the past month only. These questions are consolidated to create seven distinct "component" scores, each with a scoring range of 0-3 points. It is important to note that a score of "0" indicates the absence of any difficulties, while a score of "3" signifies the presence of severe difficulties. Subsequently, the seven component scores are combined to generate a single "global" score, spanning from 0 to 21 points. Within this framework, a score of "0" indicates the absence of any difficulties across all domains, while a score of "21" signifies the presence of severe difficulties in all areas.
Evaluation of efficacy: 5. Measurment of Montreal Cognitive Assessment Scale
Time frame: 3 Months
Cognitive function will be assessed. The Montreal Cognitive Assessment (MoCA), which is a quick screening assessment used to detect elderly people who have mild cognitive impairment (MCI). It is a single-page examination that may be performed in 10 minutes. This test has a maximum score of 30, with a result of 26 or higher deemed normal. A score of less than 26 without associated functional impairment indicates a diagnosis of mild cognitive impairment. Furthermore, a score of less than 26 combined with functional impairment implies that dementia is in its early stages. It is worth mentioning that an additional point is given whether the individual has completed 12 years of formal education or less.
Evaluation of efficacy: 6. Evaluation of serum Brain-derived neurotrophic factor:
Time frame: 3 Months
Blood sample will be withdrawn from each patient at baseline and after 3 months and separated sera will be stored at -80 C till analysis. Serum Brain-derived neurotrophic factor will be assessed for each patient using ELISA kits.
7.Incidence of Adverse Events
Time frame: 3 months
Patients will be educated about any expected side effects and will be required to report any of them.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amr Ali Mahfouz, Endocrinology consultant-PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Piracetam in people with Diabetic Peripheral Neuropathy, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamsa A. Attia (01225981809, hamsa.attia@ksiu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of efficacy:1. Measurment of McGill Pain Scale: (time frame: 3 Months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.