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

Sponsor

University of Sulaimani (Other)

Overall Status

Recruiting

CT.gov ID

NCT05172947

Collaborator

(none)

120

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathies	Dietary Supplement: Placebo controlled randomized clinical trial	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Investigator, Outcomes Assessor)

Masking Description:

A prospective double blind randomized clinical trial

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 5, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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,	Dietary Supplement: Placebo controlled randomized clinical trial The blinding will be with in the first 2 arms and within the third and fourth arms
Active Comparator: Pharmaceutical care Interventional group participants are receiving pharmaceutical care along with placebo for 3 months.	Dietary Supplement: Placebo controlled randomized clinical trial The blinding will be with in the first 2 arms and within the third and fourth arms
Experimental: Resveratrol Participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months.	Dietary Supplement: Placebo controlled randomized clinical trial The blinding will be with in the first 2 arms and within the third and fourth arms
Active Comparator: Resveratrol with pharmaceutical care Participants in this group are receiving Resveratrol 500mg capsule once daily for 3 months with pharmaceutical care.	Dietary Supplement: Placebo controlled randomized clinical trial The blinding will be with in the first 2 arms and within the third and fourth arms

Outcome Measures

Primary Outcome Measures

visual analog scale (VAS) [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) [up to 3 months]
to assess the severity of diabetic peripheral neuropathy.
The Michigan Neuropathy Screening Instrument (MNSI) [up to 3 months]
to assess the severity of diabetic peripheral neuropathy
Electroneurography [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 [up to 3 months]
using the RAND-36 health survey questionnaire
Serum neopterin levels [up to 3 months]
biochemical marker for peripheral neuropathy

Secondary Outcome Measures

The mean change in fasting blood glucose [up to 3 months]
to assess glycemic status
Mean change of glycated hemoglobin (HbA1c)-mmol/l [up to 3 months]
to assess glycemic status
Measurement of serum level of LDL, cholesterol, HDL, Triglyceride [up to 3 months]
to assess the effect of the interventions on metabolic changes

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with pain due to bilateral peripheral neuropathy caused by type 2 diabetes mellitus.
HbA1c of greater than 7%
A total symptoms score (TSS) of 7.5 points,
The daily pain must be present for at least 6 months, and the diagnosis will be confirmed by a score of at least 3 on the Michigan Neuropathy Screening Instrument (MNSI). Patients had to have a mean score of ≥4 when assessed for 24-hour average pain severity on the 11-point Likert scale (from the patient diary prior to randomization).

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.