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NCT Number: NCT05172947

Effect of Resveratrol and Pharmacist Intervention 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.

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Key information

Conditions

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

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Pharmacy-University of Sulaimani

Sulaymānīyah, 00964, Iraq

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resveratrol

Drug

This group received resveratrol with the conventional therapy

Placebo

Drug

This group received placebo with the conventional therapy

Resveratrol plus Pharmaceutical care

Other

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

Placebo+Pharmaceutical care

Other

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

Primary outcomes

  1. 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.

  2. Douleur Neuropathique 4 questionnaire (DN4)

    Time frame: up to 3 months

    to assess the severity of diabetic peripheral neuropathy.

  3. The Michigan Neuropathy Screening Instrument (MNSI)

    Time frame: up to 3 months

    to assess the severity of diabetic peripheral neuropathy

  4. 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.

  5. Assessment of Quality of Life

    Time frame: up to 3 months

    using the RAND-36 health survey questionnaire

  6. Serum neopterin levels

    Time frame: up to 3 months

    biochemical marker for peripheral neuropathy

Secondary outcomes

  1. The mean change in fasting blood glucose

    Time frame: up to 3 months

    to assess glycemic status

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

    Time frame: up to 3 months

    to assess glycemic status

  3. Measurement of serum level of LDL, cholesterol, HDL, Triglyceride

    Time frame: up to 3 months

    to assess the effect of the interventions on metabolic changes

Sponsors and collaborators

Lead sponsor

University of Sulaimani

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2021
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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