Diabetic Polyneuropathy
Conditions
Keywords
Diabetic complications, Diabetic polyneuropathy, Amylase deficiency, Licorice, FDGL
Brief summary
This double-blind, placebo-controlled study evaluated the efficacy of oral α-amylase enzyme replacement therapy in treating early-stage diabetic polyneuropathy (DPN). The study was conducted at Al-Azhar University Hospitals with 83 diabetic patients randomized to receive either fermented deglycyrrhizinated licorice extract (FDGL) containing α-amylase enzyme (2500 IU/gm) or placebo for 6 months. Primary outcomes measured improvements in nerve conduction velocity and vibration perception threshold.
Detailed description
Diabetes mellitus complications continue to develop despite optimal glycemic control with insulin. Recent studies suggest that serum amylase deficiency correlates with the severity of diabetic complications. This study hypothesizes that α-amylase enzyme deficiency represents an enzymatic defect in the cascade between activated insulin receptors and mitochondrial energy liberation, contributing to diabetic complications. α-amylase is a glycolytic enzyme that undergoes entero-pancreatic circulation and is proposed to be a precursor to key phosphorylating enzymes (glycogen phosphorylase, glucokinase, and hexokinase) essential for glycolysis. Supplementation with α-amylase may restore normal carbohydrate metabolism and prevent diabetic complications. The study drug is a formulation rich in α-amylase enzyme prepared from fermented deglycyrrhizinated licorice root extract, also containing acid-lipase enzyme and naturally occurring flavonoids. The intervention was administered as 500mg capsules twice daily, one hour before meals, for 6 months alongside regular antidiabetic medications.
Interventions
DRUGFermented Deglycyrrhizinated Licorice
Oral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day).
DIETARY_SUPPLEMENTNon-fermented Deglycyrrhizinated Licorice
500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus * Age between 15 and 65 years * Diabetes duration of 1-5 years * Body Mass Index (BMI) \< 30 kg/m² * HbA1c \< 9% * Serum creatinine \< 2mg/dL * Serum α-amylase \< 45 IU/L (reference range: 28-100 IU/L) * Vibration Perception Threshold (VPT) \> 15V * Absence of clinical symptoms of diabetic polyneuropathy
Exclusion criteria
* Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents) * Presence of myopathies * Presence of neuropathies from other causes * Presence of malignancies * Clinical symptoms of diabetic polyneuropathy * Inability to comply with study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Nerve Conduction Velocity (SCV) | Baseline, 3 months, 6 months | Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Nerve Conduction Velocity (MCV) | Baseline, 3 months, 6 months | Measurement of nerve conduction velocity in peroneal nerve using digital electromyography equipment |
| Vibration Perception Threshold (VPT) | Baseline, 3 months, 6 months | Measurement using biothesiometer at six points on each foot (big toe, metatarsal bases, instep, heel) |
| Serum α-amylase Levels | Baseline, 3 months, 6 months | Measurement of serum α-amylase concentration as marker of compliance and drug efficacy |
| Sensory Nerve Action Potential Amplitude (SNAP) | Baseline, 3 months, 6 months | Amplitude measurement in sural nerve |
| Compound Muscle Action Potential Amplitude (CMAP) | Baseline, 3 months, 6 months | Amplitude measurement in peroneal nerve |
Countries
Egypt
Outcome results
None listed