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.
1 other identifier
interventional
62
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Mar 2022
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 27, 2026
CompletedMarch 31, 2026
March 1, 2026
5 months
March 16, 2026
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Lipid Profile Levels
Lipid Profile Levels (Lipid profile levels (Total, HDL, LDL cholesterol, and Triglycerides) are primarily measured in milligrams per deciliter (mg/dL)
up to 4 months
Blood Glucose
Fasting blood glucose (FBG) (mg/dL) + Glycosylated hemoglobin (HbA1C) (%)
up to 4 months
Body Mass Index
Body Mass Index using (Weight in Kg/Height in m2). Weight and height will be combined to report BMI in kg/m\^2
up to 4 months
Pain levels
Pain levels using Pain numeric Rating Scale form 0 to 10
up to 4 months
Study Arms (1)
Diabetic Educational Intervention and Dietary Supplements
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- adult patients (aged 18 years or older)
- diagnosed with painful diabetic peripheral neuropathy at Ministry of Health Clinics in 2021.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Quds University
East Jerusalem, Abu Dies, Palestinian Territories
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 27, 2026
Study Start
March 1, 2022
Primary Completion
August 1, 2022
Study Completion
August 1, 2022
Last Updated
March 31, 2026
Record last verified: 2026-03