PainNCT07496619
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 study testing Diabetic Educational Intervention and Dietary Supplements in people with Pain and Glucose Levels, run by Al-Quds University at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Glucose Levels, Low-density Lipoprotein Lipid Composition
- What is being tested?
- Diabetic Educational Intervention and Dietary Supplements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Mar 2022to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patients (aged 18 years or older)
- diagnosed with painful diabetic peripheral neuropathy at Ministry of Health Clinics in 2021.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Al-Quds University
East Jerusalem, Abu Dies
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Pain, Glucose Levels, Low-density Lipoprotein Lipid Composition, Cholesterol (Total and HDL)
- Being tested
- Diabetic Educational Intervention and Dietary Supplements
- Keywords
- Diabetic educational intervention, Painful diabetic peripheral neuropathy, Cinnamon supplementation, Insulin resistance, Blood glucose, Lipid profile.
- Medical subject headings
- Pain, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic Educational Intervention and Dietary SupplementsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Diabetic Educational Intervention and Dietary Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipid Profile Levels
Lipid Profile Levels (Lipid profile levels (Total, HDL, LDL cholesterol, and Triglycerides) are primarily measured in milligrams per deciliter (mg/dL)
Measured: up to 4 months
Blood Glucose
Fasting blood glucose (FBG) (mg/dL) + Glycosylated hemoglobin (HbA1C) (%)
Measured: 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
Measured: up to 4 months
Pain levels
Pain levels using Pain numeric Rating Scale form 0 to 10
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Quds University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Jehad Abuejheisheh, Al-Quds University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496619
- Sponsor's protocol ID
- MOH Jordan (No: 99011)
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07496619
- Acronym / sponsor ID
- MOH Jordan (No: 99011)
- Conditions
- Pain, Glucose Levels, Low-density Lipoprotein Lipid Composition, Cholesterol (Total and HDL)
- Keywords
- Diabetic educational intervention, Painful diabetic peripheral neuropathy, Cinnamon supplementation, Insulin resistance, Blood glucose, Lipid profile.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Al-Quds UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetic Educational Intervention and Dietary Supplements | Experimental | Other: Diabetic Educational Intervention and Dietary SupplementsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patients (aged 18 years or older)
- diagnosed with painful diabetic peripheral neuropathy at Ministry of Health Clinics in 2021.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetic Educational Intervention and Dietary SupplementsThe 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 |
Primary outcome
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)
Blood Glucose
Time frame: up to 4 months
Fasting blood glucose (FBG) (mg/dL) + Glycosylated hemoglobin (HbA1C) (%)
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
Pain levels
Time frame: up to 4 months
Pain levels using Pain numeric Rating Scale form 0 to 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetic Educational Intervention and Dietary Supplements in people with Pain and Glucose Levels, run by Al-Quds University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Profile Levels (time frame: up to 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.