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NCT Number: NCT07496619

Effects of Diabetic Educational Intervention and Dietary Supplements on Blood Glucose, Lipid Profile Levels, Body Mass Index, and Pain Management Among Adult Individuals With Painful Diabetic Peripheral Neuropathy.

The purpose of this study was to assess the effects of a diabetes education intervention with cinnamon supplement on blood glucose, lipid profile, body mass index (BMI), and peripheral neuropathy pain in adults with type 2 diabetes.

A quasi-experimental pretest/post-test design was employed, with data collected from March to August 2022 at endocrinology clinics at the Ministry of Health Clinics in Jordan. The study included 62 adults with PDPN, who were randomly assigned to either an experimental or a control group. Data were collected at baseline, 3 months, and 6 months using clinical and biochemical assessments and the Numeric Rating Scale for pain.

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Key information

Conditions

Pain Cholesterol (Total and HDL) Glucose Levels Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Low-density Lipoprotein Lipid Composition Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Quds University

East Jerusalem, Abu Dies, Palestinian Territories

About this study

Background: Painful diabetic peripheral neuropathy (PDPN) is a common complication of type 2 diabetes mellitus (T2DM), often preceded by insulin resistance (IR). Food supplements, especially cinnamon, along with educational interventions, have shown positive effects on long-term diseases, such as diabetes.

Aim: The purpose of this study was to assess the effects of a diabetes education intervention with cinnamon supplement on blood glucose, lipid profile, body mass index (BMI), and peripheral neuropathy pain in adults with type 2 diabetes.

Methods: A quasi-experimental pretest/post-test design was employed, with data collected from March to August 2022 at endocrinology clinics at the Ministry of Health Clinics in Jordan. The study included 62 adults with PDPN, who were randomly assigned to either an experimental or a control group. Data were collected at baseline, 3 months, and 6 months using clinical and biochemical assessments and the Numeric Rating Scale for pain.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult patients (aged 18 years or older)
  • diagnosed with painful diabetic peripheral neuropathy at Ministry of Health Clinics in 2021.

Exclusion criteria

  • Participants with chronic conditions such as chronic kidney disease (CKD).
  • Hypertension patients.
  • Cardiovascular disease (CVD).
  • Other coexisting medical issues, including cognitive impairment or sensory impairments (e.g., reading or hearing difficulties).
  • Individuals who had received treatments that could influence blood glucose levels or pain perception during basic insulin and peripheral neuropathy (PNP) therapy (such as glucocorticoids, weight-loss medications, or therapies related to vitamin B12 or iron supplementation).

Treatment and study plan

Diabetic Educational Intervention and Dietary Supplements

Other

The structured educational intervention and dietary supplementation model was specifically designed for adult patients with painful diabetic peripheral neuropathy. It was developed by the authors based on a review of relevant literature and aligned with the self-management efficacy philosophy. The model covered the following topics: information about DM and PDPN, diabetes complications, prevention through self-car, self-efficacy towards the management of PDPN, diabetes self-care activities include medication administration, blood glucose self-analysis, and foot care, compliance and lifestyle modification such as a healthy diet adapted to the diabetic individual, physical exercise, quitting smoking, regular follow-up, and weight control, self-efficacy towards the management of hyperglycemia and hypoglycemia, pain management, and information about cinnamon supplementation.

Primary outcomes

  1. Lipid Profile Levels

    Time frame: up to 4 months

    Lipid Profile Levels (Lipid profile levels (Total, HDL, LDL cholesterol, and Triglycerides) are primarily measured in milligrams per deciliter (mg/dL)

  2. Blood Glucose

    Time frame: up to 4 months

    Fasting blood glucose (FBG) (mg/dL) + Glycosylated hemoglobin (HbA1C) (%)

  3. Body Mass Index

    Time frame: up to 4 months

    Body Mass Index using (Weight in Kg/Height in m2). Weight and height will be combined to report BMI in kg/m^2

  4. Pain levels

    Time frame: up to 4 months

    Pain levels using Pain numeric Rating Scale form 0 to 10

Sponsors and collaborators

Lead sponsor

Al-Quds University

Other

Registry information

Official study title

Effects of Diabetic Educational Intervention and Dietary Supplements on Blood Glucose, Lipid Profile Levels, Body Mass Index, and Pain Management Among Adult Individuals With Painful Diabetic Peripheral Neuropathy: A Quasi-Experimental Study

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2026
Registry last updated
Mar 31, 2026

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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