NCT07496619

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

March 16, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Diabetic educational interventionPainful diabetic peripheral neuropathyCinnamon supplementationInsulin resistanceBlood glucoseLipid profile.

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

EXPERIMENTAL

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.

Other: Diabetic Educational Intervention and Dietary Supplements

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.

Diabetic Educational Intervention and Dietary Supplements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

PainInsulin Resistance

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

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

Locations