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

NCT05172947 | Completed DMC

• 1 other identifier: University of Sulaimani
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Neuropathies

Keywords

Diabetic neuropathy; Neuropathic pain; pharmaceutical care; Resveratrol

Outcome Measures

Primary Outcomes (6)

• 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

• Douleur Neuropathique 4 questionnaire (DN4)

  to assess the severity of diabetic peripheral neuropathy.

  up to 3 months

• The Michigan Neuropathy Screening Instrument (MNSI)

  to assess the severity of diabetic peripheral neuropathy

  up to 3 months

• Electroneurography

  Motor nerve conduction velocity (m/s), sensory nerve conduction velocity(m/s) will be measured using surface electrodes.

  up to 3 months

• Assessment of Quality of Life

  using the RAND-36 health survey questionnaire

  up to 3 months

• Serum neopterin levels

  biochemical marker for peripheral neuropathy

  up to 3 months

Secondary Outcomes (3)

• The mean change in fasting blood glucose

  up to 3 months

• Mean change of glycated hemoglobin (HbA1c)-mmol/l

  up to 3 months

• Measurement of serum level of LDL, cholesterol, HDL, Triglyceride

  up to 3 months

Study Arms (4)

Resveratrol

ACTIVE COMPARATOR

Interventional group, participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months.

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,

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.

Other: Resveratrol plus Pharmaceutical care

Placebo with pharmaceutical care

OTHER

Interventional group, participants are receiving placebo along with pharmaceutical care for 3 months.

Other: Placebo+Pharmaceutical care

Interventions

Resveratrol DRUG

This group received resveratrol with the conventional therapy

Resveratrol

Placebo DRUG

This group received placebo with the conventional therapy

Placebo

Resveratrol plus Pharmaceutical care OTHER

This group received Resveratrol with Pharmaceutical care in addition to the conventional therapy

Resveratrol plus Pharmaceutical care

Placebo+Pharmaceutical care OTHER

This group received placebo with Pharmaceutical care in addition to the conventional therapy

Placebo with pharmaceutical care

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (1)

College of Pharmacy-University of Sulaimani

Sulaymānīyah, 00964, Iraq

Location

Related 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.

  PMID: 30565054 BACKGROUND

• 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.

  PMID: 20961643 BACKGROUND

• 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.

  PMID: 29627577 BACKGROUND

• 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.

  PMID: 31352568 BACKGROUND

• 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.

  PMID: 31346658 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia

Interventions

Resveratrol; Pharmaceutical Services

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bushra Marouf, PhD

  Department of Pharmacology and Toxicology-College of Pharmacy-University of Sulaimani

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A prospective triple blind randomized clinical trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at Pharmacology and Toxicology Department

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 29, 2021
• Study Start: December 5, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 15, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)