The efficacy of cGP in vascular complications in patients with diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged between 45 and 80 years old 2. More than 8 years of medical history of Type 2 Diabetes Mellitus (T2DM) 3. Current diagnosis of foot diabetic peripheral neuropathy (DPN) 4. Diagnosis of T2DM based on: 4.1. Fasting glucose = 7 mmol/L and/or 4.2. HbA1c = 6.5% 5. Diagnosis of foot DPN based on: 5.1. Self-reporting symptoms 5.2. Foot sensory testing scores 6. Inclusion criteria are independent of: 6.1. Body Mass Index (BMI) 6.2. Blood pressure 6.3. Plasma lipid profiles 6.4. Other complications of T2DM
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Diabetic foot ulcers 3. Any other cause of peripheral neuropathy (drug or injury or Covid-19 associated peripheral neuropathy) 4. Medical history of degenerative neurological conditions 5. History of cognitive impairment 6. Major mental health issues such as: 6.1. Schizophrenia 6.2. Severe depression 6.3. Anxiety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Foot sensation measured using Semmes-Weinstein monofilament, vibration and warm/cold perception threshold tests at three hospital visits (Before supplementation, after 3 months of supplementation, and after 6 months of supplementation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured before supplementation, after 3 months of supplementation, and after 6 months of supplementation: 1. Systolic and diastolic blood pressure measured using a sphygmomanometer at three hospital visits 2. Glucose intolerance measured using fasting blood glucose, HBA1c (%), and triglyceride/glucose index at three hospital visits | — |
Countries
China