The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient
NCT Number: NCT06568185
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Diabetic Polyneuropathy
Interventions: DRUG: Alpha-Lipoic Acid/Vitamin/Mineral Supplement PolyMVA
Sponsor: Universiti Sains Malaysia
Collaborators: BREGO Life Sciences Sdn Bhd
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 76
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-27
Completion Date: 2025-09-01
Locations: Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, 16150, Malaysia

Summary:
To evaluate the efficacy of combination of vitamin B and alpha lipoic acid formulations for the treatment of diabetic polyneuropathy in individuals with type 2 diabetes mellitus.

Methodology :

This is a single-center, randomized, double-blind, placebo-controlled trial study.

Study duration May 2024 - September 2025

Study location :

This study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia.

Source Reference :

People with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia.

Study source population :

People with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period.

Primary Outcome Measures: To compare the mean change in Total symptom score (TSS) over 12 a week period, Total Symptom Score is the sum of 4 neuropathic symptoms (stabbing pain, burning pain, paraesthesia, and numbness) reported as symptoms frequency (occasionally, frequent, or continuous) and symptom intensity (absent, slight, moderate, or severe) on which scores range from 0 to 14.64., baseline, 6 weeks and 3 month|To compare the mean change in Neuropathic symptoms score (NSS) over 12 a week period, Neurological Symptom Score consists of 4 components. The first component is on reported discomfort symptoms: burning/numbness/tingling (2 points), fatigue/cramping and aching feelings (1point) and 0 point for none. Second component is on symptom location whether the symptom occurs in the feet (2 points), calves (1 point) and 0 points for elsewhere. The third component is on timing of symptoms, either nocturnal exacerbation (2 points), symptoms present both day and night (1 point) and 0 for symptoms present during daytime only. A score of 1 was added if the symptoms had ever woken the patient from sleep. The fourth component is on a manoeuvre to reduce the symptoms by either walking (2 points) or standing (1pointand and 0 for sitting or lying down. The maximum symptom score was 9., baseline, 6 weeks and 3 month
Secondary Outcome Measures: compare the changes in the fasting plasma glucose over 12 a week period, A fasting blood glucose test measures the amount of glucose in blood after a period of fasting (usually 8-12 hours). Fasting plasma glucose will be measure in millimoles per liter (mmol/L). The participants fasts overnight, usually for 8 hours before the test., baseline and 3 month|compare the changes in the fasting lipid profile over 12 a week period, A fasting lipid profile (or lipid panel) measures the levels of various types of fats in the blood, including Total Cholesterol, High-Density Lipoprotein (HDL) Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol and triglycerides. Fasting lipid profile will be measure in millimoles per liter (mmol/L). Patients are usually advised to fast overnight, avoiding food and drinks (except water) for 8 hours before the test., baseline and 3 month|compare the changes in the HbAIC level over 12 a week period, The HbA1c test reflects the average blood glucose levels by measuring the percentage of glycated hemoglobin (hemoglobin bound with glucose) and is an important indicator of long-term blood sugar control. The HbA1c results are reported as a percentage (%) of glycated hemoglobin. The target HbA1C level for most diabetic individuals is typically below 7% to reduce the risk of diabetes-related complications., baseline and 3 month|compare the changes in blood pressure over 12 a week period, A blood pressure cuff is placed around the upper arm and inflated. The cuff then deflates while measuring the pressure in the arteries. The measurement is taken with an electronic sphygmomanometer. Blood pressure is measured in millimeters of mercury (mmHg). Normal Blood Pressure is systolic less than 120 mmHg and diastolic less than 80 mmHg., baseline and 3 month|compare the changes in diabetes quality of life over 12 a week period, using the revised version of Diabetes Quality of Life (Rv-DQoL) questionnaire. DQoL used for evaluating the quality of life specifically related to Type 2 Diabetes Mellitus patient and was made up of three major domains, namely, (i) Diabetes Life Satisfaction (QoL Satisfy), 18 items; (ii) Disease Impact Scale (QoL Impact), 27 items; and (iii) Disease-Related Worries Scale (QoL Worry), 14 items and one general question to reflect self-rating of overall general health. All items in the QoL Satisfy domain are scored on a five-point scale, ranging from 1 (very satisfied) to 5 (very dissatisfied), whereas the items in the QoL Impact and QoL Worry are scored on a five-point scale, ranging from 1 (never) to 5 (all the time); the score was presented as the total of the items of each scale divided by the number of items. A higher average score indicates poorer QoL., baseline, 6 weeks and 3 month|compare the differences in the safety parameters of renal function, The test conducted to assess kidney function include Blood Urea Nitrogen (BUN), Serum Creatinine and Estimated Glomerular Filtration Rate (eGFR). Blood Urea Nitrogen (BUN) measure in mg/dL which the Normal Range: 7 to 20 mg/dL. Serum Creatinine measure in Micromoles per liter (µmol/L) Normal Range for Men: Approximately 70 to 120 µmol/L while Women: Approximately 50 to 100 µmol/L. Estimated Glomerular Filtration Rate (eGFR) normal range: 90 to 120 mL/min/1.73 m². Values below 60 mL/min/1.73 m² suggest CKD (Chronic Kidney Disease)., baseline and 3 month|compare the differences in the safety parameters of liver function, Liver function tests (LFTs) in encompass a range of blood tests that assess the health and function of the liver. This include: 1) Alanine Aminotransferase (ALT) which typically below 40 international units per liter (IU/L) for men and below 30 IU/L for women. 2) Aspartate Aminotransferase (AST) with normal range usually below 40 IU/L for both men and women. 3) Alkaline Phosphatase (ALP) varies by age and gender, typically between 30 and 120 IU/L., baseline and 3 month|compare the changes in participant weight., participant weight will be measure in kilograms (kg) using electronic bathroom scale., baseline, 6 weeks and 3 month|participant height., participant height measurement will be measure using a stadiometer. It consists of a vertical ruler and a movable headpiece that is adjusted to rest on the top of the head. Height measurement is in Centimeters (cm)., baseline|compare the changes in participant Body Mass Index (BMI), Body Mass Index (BMI) is used to measure whether a person is underweight, normal weight, overweight, or obese. It is calculated by dividing weight in kilograms by height in meters squared (BMI = weight(kg) / height(m)\^2). In Malaysia, the Clinical Practice Guidelines (CPG) on the Management of Obesity provide specific classifications for Body Mass Index (BMI) to identify and manage obesity. Underweight: BMI \< 18.5. Normal Weight: BMI 18.5-22.9. Overweight: BMI 23.0-27.4. Obesity Class I: BMI 27.5-34.9. Obesity Class II: BMI 35.0-39.9. Obesity Class III (Morbid Obesity): BMI ≥ 40.0., baseline, 6 weeks and 3 month