- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Abu Dies
-
East Jerusalem, Abu Dies, Palestinian Territories
- Al-Quds University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetic Educational Intervention and Dietary Supplements
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
up to 4 months
|
|
Blood Glucose
Time Frame: up to 4 months
|
Fasting blood glucose (FBG) (mg/dL) + Glycosylated hemoglobin (HbA1C) (%)
|
up to 4 months
|
|
Pain levels
Time Frame: up to 4 months
|
Pain levels using Pain numeric Rating Scale form 0 to 10
|
up to 4 months
|
|
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
|
up to 4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Metabolic Diseases
- Glucose Metabolism Disorders
- Hyperinsulinism
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Pain
- Insulin Resistance
- Food
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Dietary Supplements
Other Study ID Numbers
- MOH Jordan (No: 99011)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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