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Material and Methods:
This study was conducted on 60 samples of enrolled participants in the age group of 18-80 years with type 2 Diabetes Mellitus who visited the OPD/IPD of Geetanjali Medical College and Hospital, Udaipur. The patients were divided into two groups (n=30 in each group) depending on whether they were on metformin therapy or not.
After enrolment, a detailed history was noted down including age, gender, chief complaint present, family history, duration of disease, and duration of metformin therapy. A thorough general physical examination and clinical examination by Toronto clinical scoring system (TCSS) scoring were also done.
This study was approved previously by the appropriate institutional ethics committee and performed in accordance with the ethical standards. Informed consent was obtained from all individual participants included in the study.
Study Design
A prospective case-control study in which participants enrolled according to inclusion and exclusion criteria.
Inclusion criteria
? Cases: Patients with Type 2 Diabetes Mellitus with symptomatic peripheral neuropathy on Metformin therapy for more than 6 months.
? Controls: Patients with Type 2 Diabetes Mellitus with symptomatic peripheral neuropathy not on Metformin exposure.
Exclusion criteria
? Unwilling patients.
? Previously treated with Metformin and had discontinued therapy within the last 6 months.
? Patients who have received less than 6 months of Metformin treatment at the time of assessment.
? If patients only had impaired glucose tolerance.
? Patients on vitamin B12 and calcium supplements and neuroprotective drugs.
? Patients with potential causes for peripheral neuropathy other than diabetes and vitamin B12 deficiency.
? Malabsorption (colic disease, IBD, Gastro-intestinal surgery).
? Type 1 Diabetes Mellitus.
? Patients diagnosed having other forms of neuropathy.
? Alcoholism
? Vitamin B12 deficiency
Data collection method
After the selection of subjects and after obtaining informed consent, about 5ml of venous blood was obtained by venipuncture by using sterile gloves and thorough disinfection of venepuncture site, using 70% ethyl alcohol. Blood was used for estimation of parameters required for the study.
? Serum Vitamin B12 levels and Serum Homocysteine levels.
? Complete Blood Count
? Renal Function Test.
? Liver Function Test
? Thyroid Stimulating Hormone Test.
? Blood Glucose level
? Routine biochemical and hematological test and glycosylated hemoglobin, HbA1C.
A detailed history will be taken and patients will be examined thoroughly for any further complications. Neurological examination by Toronto Clinical Scoring System (TCSS) was conducted and registered into a computerized data sheet. The TCSS scores were compared in the patients on Metformin and without Metformin therapy and the results were correlated statistically. The TCSS was conducted on the following points
? Motor and sensory nerve conduction studies.
? Duration of diabetes.
? Duration of Metformin intake and dosage history.
? Duration of clinical symptoms and signs of diabetic peripheral neuropathy.