Painful Diabetic Peripheral Neuropathy (PDPN), Type 2 Diabetes Mellitus
Conditions
Keywords
Ceylon Cinnamon, Self-Efficacy Educational Program, Glycemic Control, Neuropathic Pain, Randomized Controlled Trial
Brief summary
This randomized controlled trial aims to evaluate the therapeutic effects of pure Ceylon cinnamon (Cinnamomum verum) supplementation combined with a structured self-efficacy-based educational program on glycemic control, lipid profiles, and neuropathic pain in adult patients with type 2 diabetes mellitus (T2DM) and painful diabetic peripheral neuropathy (PDPN). A total of 900 participants will be randomly assigned to three parallel arms: a standard care control group, a Ceylon cinnamon supplementation group (1,000 mg/day), and a combined intervention group (Ceylon cinnamon supplementation plus the self-efficacy educational program) over a 6-month period. The study hypothesizes that the combined approach will significantly improve glycemic parameters, reduce neuropathic pain severity, and enhance metabolic profiles compared to standard care alone.
Detailed description
Type 2 diabetes mellitus (T2DM) is a major global health challenge often complicated by diabetic peripheral neuropathy (DPN), which frequently manifests as painful diabetic peripheral neuropathy (PDPN) and severely compromises patients' quality of life. Conventional pharmacological treatments for PDPN often produce limited efficacy and adverse side effects, necessitating safe and effective complementary interventions. This study is a prospective, three-group, parallel-arm, randomized controlled trial (RCT) designed to investigate the synergistic therapeutic impact of botanical supplementation and behavioral education. A total of 900 eligible adult participants diagnosed with T2DM and PDPN attending clinical healthcare centers will be enrolled and randomly allocated in a 1:1:1 ratio into one of three trial arms: Control Group (Standard Care, n = 300): Participants receive routine diabetic medical care, standard counseling, and matching placebo capsules administered twice daily for 6 months, without structured educational interventions. Cinnamon Supplementation Group (n = 300): Participants receive standard routine care alongside pure Ceylon cinnamon (Cinnamomum verum) extract capsules (500 mg orally twice daily with meals, total daily dose: 1,000 mg) for 6 months, combined with a double-blind placebo control for the educational component. Combined Intervention Group (n = 300): Participants receive the identical daily regimen of 1,000 mg Ceylon cinnamon supplementation for 6 months, integrated with a structured, theory-driven Self-Efficacy-Based Educational Program grounded in Bandura's social cognitive theory. The educational program focuses on self-monitoring of blood glucose (SMBG), medication and supplement adherence, dietary modifications, foot care, and psychological coping strategies for chronic pain. Primary and Secondary Endpoints: Evaluations will be conducted at baseline and 6 months post-intervention. Primary outcomes include changes in glycated hemoglobin (HbA1c), fasting blood glucose (FBG), insulin resistance (HOMA-IR), and neuropathic pain severity assessed via the Numeric Rating Scale (NRS). Secondary outcomes include lipid profile biomarkers (Total Cholesterol, Triglycerides, LDL-C, and HDL-C), patient adherence, and safety/adverse event tracking. Statistical analyses will utilize repeated measures ANOVA and mixed-model frameworks to evaluate longitudinal and between-group differences.
Interventions
DIETARY_SUPPLEMENTCeylon Cinnamon (Cinnamomum verum) Supplement
Pure Ceylon cinnamon extract capsules (500 mg per capsule, taken twice daily, total dose 1,000 mg/day for 6 months).
OTHERMatching Placebo
Placebo capsules identical in appearance, color, and packaging to the cinnamon supplement, taken twice daily for 6 months
BEHAVIORALSelf-Efficacy-Based Educational Program
A structured educational program grounded in Bandura's social cognitive theory aimed at enhancing self-efficacy and self-management skills evaluated using the Diabetes Self-Efficacy Scale (DSES)in participants with diabetes
Sponsors
Jerash Private University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
A double-blind, placebo-controlled design is implemented for the supplementation component (participants, care providers, investigators, and outcomes assessors are blinded to the cinnamon vs. placebo assignment). The educational intervention component is open-label for participants and educators, but outcomes assessors and data analysts remain blinded to group allocations.
Intervention model description
A prospective, three-group, parallel-arm, randomized controlled trial where eligible participants are allocated in a 1:1:1 ratio into three study arms: a standard care control group, a Ceylon cinnamon supplementation group, and a combined intervention group (Ceylon cinnamon supplementation plus a self-efficacy educational program).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 6 months. * Confirmed diagnosis of painful diabetic peripheral neuropathy (PDPN). * Age between 18 and 65 years. * Able to provide written informed consent and willing to comply with the study protocol, supplement intake, and educational sessions.
Exclusion criteria
* Type 1 diabetes mellitus or gestational diabetes. * Severe renal or hepatic impairment. * Known allergy, hypersensitivity, or contraindication to cinnamon or related botanical products. * Pregnancy or lactation. * Concurrent participation in another clinical trial or severe psychiatric/cognitive disorders that hinder study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated Hemoglobin (HbA1c) | Baseline and 6 months | Evaluated from venous blood samples to assess glycemic control over the preceding 2 to 3 months, expressed as a percentage (%). Lower values indicate a better outcome (improved long-term glycemic control). Normal reference ranges typically fall below 5.7%, with diabetes management targets generally aiming for levels below 7.0% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Glucose (FBG) | Baseline, 3 months, and 6 months | Description: Evaluated from venous blood samples collected following an 8-hour overnight fast, measured in milligrams per deciliter (mg/dL). Lower values indicate a better outcome (improved fasting glycemic status). |
| Change in Lipid Profile Parameters | Baseline and 6 months | Evaluated from venous blood samples collected following an 8-hour overnight fast, measured in milligrams per deciliter (mg/dL). Directionality of improvement varies by component: Total Cholesterol: Lower values indicate a better outcome. Triglycerides: Lower values indicate a better outcome. Low-Density Lipoprotein Cholesterol (LDL-C): Lower values indicate a better outcome. High-Density Lipoprotein Cholesterol (HDL-C): Higher values indicate a better outcome. |
| Change in Neuropathic Pain Intensity | Baseline and 6 months (or Baseline, 3 months, and 6 months according to your protocol) | Evaluated using the Numerical Rating Scale (NRS). Participants rate their average neuropathic pain intensity over the preceding 7 days. Scores range from a minimum value of 0 (no pain) to a maximum value of 10 (worst possible pain). Higher scores indicate a worse outcome (greater pain intensity). Pain severity is categorized as mild (1-3), moderate (4-7), or severe (8-10). |
| Change in Diabetes Self-Efficacy Score | Baseline and 6 months | Evaluated using the Diabetes Self-Efficacy Scale (DSES). Item scores range from a minimum value of 1 (not at all confident) to a maximum value of 10 (totally confident), reported as an overall mean score (range 1-10). Higher scores indicate |
Contacts
CONTACTDr. Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
Outcome results
None listed