Diabetic NeuropathiesNCT05172947
Effect of Resveratrol and Pharmacist Intervention on Diabetes Mellitus and Its Neuropathic Complication
A study testing Resveratrol and Resveratrol plus Pharmaceutical care in people with Diabetic Neuropathies, run by University of Sulaimani at 1 site in Iraq.
Trial summary
Management of symptoms associated with diabetic neuropathy is a difficult issue for clinicians since it usually does not respond to standard analgesics. Resveratrol is a naturally occurring plant-derived, polyphenolic compound, it exerts pleiotropic activity. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Resveratrol and Resveratrol plus Pharmaceutical care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 5 Dec 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pain due to bilateral peripheral neuropathy caused by type 2 diabetes mellitus.
- HbA1c of greater than 7%
- The daily pain must be present for at least 6 months, and the diagnosis will be confirmed by a score >4 on the Michigan Neuropathy Screening Instrument (MNSI), Douleur Neuropathique 4 (DN4). The severity of pain when evaluated for the past 24 was ≥4 on the 10 cm Visual Analogue Scale (VAS) at baseline without the use of analgesic for 48 hours.
Who cannot join
- Older subjects with high risks of cardiovascular diseases,
- Pregnant or breastfeeding,
- Having a prior renal transplant or current renal dialysis,
- Patients have a diagnosis of major depressive disorder, generalized anxiety disorder, heavy alcohol drinkers,
- Significant hepatic or renal disease,
- Patients on antioxidant therapy, or pentoxyphylline within the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Resveratrol and Pharmaceutical Care on Diabetes Mellitus and Its Neuropathic Complication
Management of symptoms associated with diabetic neuropathy is a difficult issue for clinicians since it usually does not respond to standard analgesics. Resveratrol is a naturally occurring plant-derived, polyphenolic compound, it exerts pleiotropic activity. The investigators believed that the implementation of multidisciplinary approaches including pharmacotherapy and provision of healthcare professional services such as pharmacist intervention are needed for alleviation of diabetic associated neuropathy.Therefore, the hypothesis of the present protocol is that the administration of resveratrol and/or provision of pharmaceutical care in patients with diabetic neuropathy might be of value in improving quality of life and managing diabetic neuropathic pain.The study is designed as a four-arm randomized, placebo-controlled clinical trial. Group one will be given only conventional hypoglycemic drugs. Group two patients will receive conventional hypoglycemic drugs accompanied by pharmacist interventions. Group three; patients will receive resveratrol 500 mg orally once daily after meals for three months, in addition to their regular hypoglycemic drugs. Group four; patients will receive resveratrol 500 mg orally once daily after meals along with their regular hypoglycemic drugs for a period of three months, accompanied by pharmacist interventions. Neuropathic pain will be measured by various neuropathic pain assessment tools. Nerve conduction studies will be performed to assess the effect of interventional therapy. The expected outcome will be the improvement of diabetic neuropathy associated symptoms along with glycemic status.
Read the detailed description
- Diabetic neuropathy is the most common microvascular complication of diabetes, resulting from prolonged periods of hyperglycemia, damaging fragile nerve fibers and the walls of their blood vessels.
- Despite clinical developments in the treatment of diabetes complications, especially diabetic neuropathy, it still remains a clinical challenge with no effective solution.
- Conventional therapies such as anti-epileptics, opioid analgesics, and antidepressants for the treatment of neuropathic pain are quite challenging due to their serious adverse effects.
- There is a need to investigate novel effective and safe options.
- Recently, polyphenols have also been introduced as potential neuroprotective agents in diabetes.
- Alleviation of the symptoms associated with diabetic neuropathy and exerting preventive measures to halt the emergence of neuropathy complications are crucial priorities, and this requires multidisciplinary approaches including pharmacotherapy and provision of healthcare professional services such as pharmacist intervention.
- Aim of the study: to evaluate the effects of resveratrol and pharmaceutical care on the severity of diabetic neuropathy and improvement in the quality of life of diabetic patients.
- Study design: four-arm randomized, double-blind, placebo-controlled clinical trial.
- Interventions:Therapeutic intervention and Pharmacist intervention.
- Number of participants = 120
- Number of groups = 4 groups each of 30 patients
- Conditions
- Diabetic Neuropathies
- Being tested
- Resveratrol, Placebo, Resveratrol plus Pharmaceutical care, Placebo+Pharmaceutical care
- Keywords
- Diabetic neuropathy, Neuropathic pain, pharmaceutical care, Resveratrol
- Medical subject headings
- Diabetic Neuropathies, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
This group received resveratrol with the conventional therapy
PlaceboDrug
This group received placebo with the conventional therapy
Resveratrol plus Pharmaceutical careOther
This group received Resveratrol with Pharmaceutical care in addition to the conventional therapy
Placebo+Pharmaceutical careOther
This group received placebo with Pharmaceutical care in addition to the conventional therapy
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Active comparator | Interventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months. Receives: Drug: Resveratrol |
| Placebo | Placebo comparator | Non-interventional group, participants are receiving only Placebo once daily for 3 months.
Placebo formulated as capsule match the color and size of the active comparator, Receives: Drug: Placebo |
| Resveratrol plus Pharmaceutical care | Other | Interventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months with pharmaceutical care. Receives: Other: Resveratrol plus Pharmaceutical care |
| Placebo with pharmaceutical care | Other | Interventional group, participants are receiving placebo along with pharmaceutical care for 3 months. Receives: Other: Placebo+Pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (VAS)
to assess neuropathic pain, VAS scale ranges between 0-10 , 0 indicates no pain while 10 indicates severe pain.
Measured: up to 3 months
Douleur Neuropathique 4 questionnaire (DN4)
to assess the severity of diabetic peripheral neuropathy.
Measured: up to 3 months
The Michigan Neuropathy Screening Instrument (MNSI)
to assess the severity of diabetic peripheral neuropathy
Measured: up to 3 months
Electroneurography
Motor nerve conduction velocity (m/s), sensory nerve conduction velocity(m/s) will be measured using surface electrodes.
Measured: up to 3 months
Assessment of Quality of Life
using the RAND-36 health survey questionnaire
Measured: up to 3 months
Serum neopterin levels
biochemical marker for peripheral neuropathy
Measured: up to 3 months
Secondary outcomes (3)
The mean change in fasting blood glucose
to assess glycemic status
Measured: up to 3 months
Mean change of glycated hemoglobin (HbA1c)-mmol/l
to assess glycemic status
Measured: up to 3 months
Measurement of serum level of LDL, cholesterol, HDL, Triglyceride
to assess the effect of the interventions on metabolic changes
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start5 Dec 2021
- Primary completion1 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients assigned to either conventional hypoglycemic drugs without pharmaceutical care, or conventional hypoglycemic drugs accompanied with pharmacist interventions or patients will receive resveratrol 500 mg capsules orally once daily with their regular hypoglycemic drugs or resveratrol 500 mg capsule orally along with their regular hypoglycemic drugs for a period of three months, accompanied with pharmacist interventions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra Hassan Marouf, University of Sulaimani
- Investigators
- Bushra Marouf, PhD, Principal investigator, Department of Pharmacology and Toxicology-College of Pharmacy-University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172947
- Sponsor's protocol ID
- University of Sulaimani
- Status last verified
- Mar 2023
- First submitted
- 30 Nov 2021
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azmi S, ElHadd KT, Nelson A, Chapman A, Bowling FL, Perumbalath A, Lim J, Marshall A, Malik RA, Alam U. Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review. Diabetes Ther. 2019 Feb;10(1):35-56. doi: 10.1007/s13300-018-0550-x. Epub 2018 Dec 18.
PubMed 30565054Collins C, Limone BL, Scholle JM, Coleman CI. Effect of pharmacist intervention on glycemic control in diabetes. Diabetes Res Clin Pract. 2011 May;92(2):145-52. doi: 10.1016/j.diabres.2010.09.023. Epub 2010 Oct 20.
PubMed 20961643Elbarbary NS, Ismail EAR, El-Hilaly RA, Ahmed FS. Role of neopterin as a biochemical marker for peripheral neuropathy in pediatric patients with type 1 diabetes: Relation to nerve conduction studies. Int Immunopharmacol. 2018 Jun;59:68-75. doi: 10.1016/j.intimp.2018.03.026. Epub 2018 Apr 6.
PubMed 29627577Naseri R, Farzaei F, Fakhri S, El-Senduny FF, Altouhamy M, Bahramsoltani R, Ebrahimi F, Rahimi R, Farzaei MH. Polyphenols for diabetes associated neuropathy: Pharmacological targets and clinical perspective. Daru. 2019 Dec;27(2):781-798. doi: 10.1007/s40199-019-00289-w. Epub 2019 Jul 27.
PubMed 31352568Eid S, Sas KM, Abcouwer SF, Feldman EL, Gardner TW, Pennathur S, Fort PE. New insights into the mechanisms of diabetic complications: role of lipids and lipid metabolism. Diabetologia. 2019 Sep;62(9):1539-1549. doi: 10.1007/s00125-019-4959-1. Epub 2019 Jul 25.
PubMed 31346658
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resveratrol and Pharmaceutical Care on Diabetes Mellitus and Its Neuropathic Complication
- ClinicalTrials.gov ID
- NCT05172947
- Acronym / sponsor ID
- University of Sulaimani
- Conditions
- Diabetic Neuropathies
- Keywords
- Diabetic neuropathy, Neuropathic pain, pharmaceutical care, Resveratrol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 5 Dec 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 29 Dec 2021 (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.
Management of symptoms associated with diabetic neuropathy is a difficult issue for clinicians since it usually does not respond to standard analgesics. Resveratrol is a naturally occurring plant-derived, polyphenolic compound, it exerts pleiotropic activity. The investigators believed that the implementation of multidisciplinary approaches including pharmacotherapy and provision of healthcare professional services such as pharmacist intervention are needed for alleviation of diabetic associated neuropathy.Therefore, the hypothesis of the present protocol is that the administration of resveratrol and/or provision of pharmaceutical care in patients with diabetic neuropathy might be of value in improving quality of life and managing diabetic neuropathic pain.The study is designed as a four-arm randomized, placebo-controlled clinical trial. Group one will be given only conventional hypoglycemic drugs. Group two patients will receive conventional hypoglycemic drugs accompanied by pharmacist interventions. Group three; patients will receive resveratrol 500 mg orally once daily after meals for three months, in addition to their regular hypoglycemic drugs. Group four; patients will receive resveratrol 500 mg orally once daily after meals along with their regular hypoglycemic drugs for a period of three months, accompanied by pharmacist interventions. Neuropathic pain will be measured by various neuropathic pain assessment tools. Nerve conduction studies will be performed to assess the effect of interventional therapy. The expected outcome will be the improvement of diabetic neuropathy associated symptoms along with glycemic status.
Detailed description
- Diabetic neuropathy is the most common microvascular complication of diabetes, resulting from prolonged periods of hyperglycemia, damaging fragile nerve fibers and the walls of their blood vessels.
- Despite clinical developments in the treatment of diabetes complications, especially diabetic neuropathy, it still remains a clinical challenge with no effective solution.
- Conventional therapies such as anti-epileptics, opioid analgesics, and antidepressants for the treatment of neuropathic pain are quite challenging due to their serious adverse effects.
- There is a need to investigate novel effective and safe options.
- Recently, polyphenols have also been introduced as potential neuroprotective agents in diabetes.
- Alleviation of the symptoms associated with diabetic neuropathy and exerting preventive measures to halt the emergence of neuropathy complications are crucial priorities, and this requires multidisciplinary approaches including pharmacotherapy and provision of healthcare professional services such as pharmacist intervention.
- Aim of the study: to evaluate the effects of resveratrol and pharmaceutical care on the severity of diabetic neuropathy and improvement in the quality of life of diabetic patients.
- Study design: four-arm randomized, double-blind, placebo-controlled clinical trial.
- Interventions:Therapeutic intervention and Pharmacist intervention.
- Number of participants = 120
- Number of groups = 4 groups each of 30 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Eligible patients assigned to either conventional hypoglycemic drugs without pharmaceutical care, or conventional hypoglycemic drugs accompanied with pharmacist interventions or patients will receive resveratrol 500 mg capsules orally once daily with their regular hypoglycemic drugs or resveratrol 500 mg capsule orally along with their regular hypoglycemic drugs for a period of three months, accompanied with pharmacist interventions.
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Active comparator | Drug: ResveratrolInterventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months. |
| Placebo | Placebo comparator | Drug: PlaceboNon-interventional group, participants are receiving only Placebo once daily for 3 months. Placebo formulated as capsule match the color and size of the active comparator, |
| Resveratrol plus Pharmaceutical care | Other | Other: Resveratrol plus Pharmaceutical careInterventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months with pharmaceutical care. |
| Placebo with pharmaceutical care | Other | Other: Placebo+Pharmaceutical careInterventional group, participants are receiving placebo along with pharmaceutical care for 3 months. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with pain due to bilateral peripheral neuropathy caused by type 2 diabetes mellitus.
- HbA1c of greater than 7%
- The daily pain must be present for at least 6 months, and the diagnosis will be confirmed by a score >4 on the Michigan Neuropathy Screening Instrument (MNSI), Douleur Neuropathique 4 (DN4). The severity of pain when evaluated for the past 24 was ≥4 on the 10 cm Visual Analogue Scale (VAS) at baseline without the use of analgesic for 48 hours.
Key exclusion criteria (6 listed)
- Older subjects with high risks of cardiovascular diseases,
- Pregnant or breastfeeding,
- Having a prior renal transplant or current renal dialysis,
- Patients have a diagnosis of major depressive disorder, generalized anxiety disorder, heavy alcohol drinkers,
- Significant hepatic or renal disease,
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 |
|---|---|---|
| ResveratrolThis group received resveratrol with the conventional therapy | Drug | Resveratrol |
| PlaceboThis group received placebo with the conventional therapy | Drug | Placebo |
| Resveratrol plus Pharmaceutical careThis group received Resveratrol with Pharmaceutical care in addition to the conventional therapy | Other | Resveratrol plus Pharmaceutical care |
| Placebo+Pharmaceutical careThis group received placebo with Pharmaceutical care in addition to the conventional therapy | Other | Placebo with pharmaceutical care |
Primary outcome
visual analog scale (VAS)
Time frame: up to 3 months
to assess neuropathic pain, VAS scale ranges between 0-10 , 0 indicates no pain while 10 indicates severe pain.
Douleur Neuropathique 4 questionnaire (DN4)
Time frame: up to 3 months
to assess the severity of diabetic peripheral neuropathy.
The Michigan Neuropathy Screening Instrument (MNSI)
Time frame: up to 3 months
to assess the severity of diabetic peripheral neuropathy
Electroneurography
Time frame: up to 3 months
Motor nerve conduction velocity (m/s), sensory nerve conduction velocity(m/s) will be measured using surface electrodes.
Assessment of Quality of Life
Time frame: up to 3 months
using the RAND-36 health survey questionnaire
Serum neopterin levels
Time frame: up to 3 months
biochemical marker for peripheral neuropathy
3 secondary outcomes
The mean change in fasting blood glucose
Time frame: up to 3 months
Mean change of glycated hemoglobin (HbA1c)-mmol/l
Time frame: up to 3 months
Measurement of serum level of LDL, cholesterol, HDL, Triglyceride
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 30565054Azmi S, ElHadd KT, Nelson A, Chapman A, Bowling FL, Perumbalath A, Lim J, Marshall A, Malik RA, Alam U. Pregabalin in the Management of Painful Diabetic Neuropathy: A Narrative Review. Diabetes Ther. 2019 Feb;10(1):35-56. doi: 10.1007/s13300-018-0550-x. Epub 2018 Dec 18.
- Background: PubMed 20961643Collins C, Limone BL, Scholle JM, Coleman CI. Effect of pharmacist intervention on glycemic control in diabetes. Diabetes Res Clin Pract. 2011 May;92(2):145-52. doi: 10.1016/j.diabres.2010.09.023. Epub 2010 Oct 20.
- Background: PubMed 29627577Elbarbary NS, Ismail EAR, El-Hilaly RA, Ahmed FS. Role of neopterin as a biochemical marker for peripheral neuropathy in pediatric patients with type 1 diabetes: Relation to nerve conduction studies. Int Immunopharmacol. 2018 Jun;59:68-75. doi: 10.1016/j.intimp.2018.03.026. Epub 2018 Apr 6.
- Background: PubMed 31352568Naseri R, Farzaei F, Fakhri S, El-Senduny FF, Altouhamy M, Bahramsoltani R, Ebrahimi F, Rahimi R, Farzaei MH. Polyphenols for diabetes associated neuropathy: Pharmacological targets and clinical perspective. Daru. 2019 Dec;27(2):781-798. doi: 10.1007/s40199-019-00289-w. Epub 2019 Jul 27.
- Background: PubMed 31346658Eid S, Sas KM, Abcouwer SF, Feldman EL, Gardner TW, Pennathur S, Fort PE. New insights into the mechanisms of diabetic complications: role of lipids and lipid metabolism. Diabetologia. 2019 Sep;62(9):1539-1549. doi: 10.1007/s00125-019-4959-1. Epub 2019 Jul 25.
- 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. This study is not recruiting at the moment.
Bushra Marouf, PhD principal investigator
Department of Pharmacology and Toxicology-College of Pharmacy-University of Sulaimani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol and Resveratrol plus Pharmaceutical care in people with Diabetic Neuropathies, run by University of Sulaimani at 1 site in Iraq.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (VAS) (time frame: up to 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172947, which also lists 5 linked publications.
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 14 Mar 2023.