Effect of Resveratrol and Pharmacist Intervention on Diabetes Mellitus and Its Neuropathic Complication

Diabetic Neuropathies Clinical Trial

Official title:

Impact of Resveratrol and Pharmaceutical Care on Diabetes Mellitus and Its Neuropathic Complication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172947
• Other study ID #: University of Sulaimani
• Status: Completed
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: March 2023
• Source: University of Sulaimani
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 15, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies

Intervention

Drug:
• Resveratrol
This group received resveratrol with the conventional therapy
• Placebo
This group received placebo with the conventional therapy

Other:
• Resveratrol plus Pharmaceutical care
This group received Resveratrol with Pharmaceutical care in addition to the conventional therapy
• Placebo+Pharmaceutical care
This group received placebo with Pharmaceutical care in addition to the conventional therapy

Locations

Country	Name	City	State
Iraq	College of Pharmacy-University of Sulaimani	Sulaymaniyah

Sponsors (1)

Lead Sponsor	Collaborator
University of Sulaimani

Country where clinical trial is conducted

Iraq, 

References & Publications (5)

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. — View Citation

Collins 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. — View Citation

Eid 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. — View Citation

Elbarbary 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. — View Citation

Naseri 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale (VAS)	to assess neuropathic pain, VAS scale ranges between 0-10 , 0 indicates no pain while 10 indicates severe pain.	up to 3 months
Primary	Douleur Neuropathique 4 questionnaire (DN4)	to assess the severity of diabetic peripheral neuropathy.	up to 3 months
Primary	The Michigan Neuropathy Screening Instrument (MNSI)	to assess the severity of diabetic peripheral neuropathy	up to 3 months
Primary	Electroneurography	Motor nerve conduction velocity (m/s), sensory nerve conduction velocity(m/s) will be measured using surface electrodes.	up to 3 months
Primary	Assessment of Quality of Life	using the RAND-36 health survey questionnaire	up to 3 months
Primary	Serum neopterin levels	biochemical marker for peripheral neuropathy	up to 3 months
Secondary	The mean change in fasting blood glucose	to assess glycemic status	up to 3 months
Secondary	Mean change of glycated hemoglobin (HbA1c)-mmol/l	to assess glycemic status	up to 3 months
Secondary	Measurement of serum level of LDL, cholesterol, HDL, Triglyceride	to assess the effect of the interventions on metabolic changes	up to 3 months