Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Dapagliflozin 10mg: Dapagliflozin 10 mg per oral will be given to patients under the intervention arm for a total duration of study i.e 24 weeks.Since 10 mg is the maximum dose of dapag
Sponsors
Postgraduate Institute of Medical Education Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Type 2 Diabetes Mellitus 5-10 years duration 2.Age 18yrs- 75 yrs 3.Presence of neuropathy at baseline (MNSI score >4 ) 4.eGFR > 30ml/min/m2 5.HBA1c between 7-10
Exclusion criteria
Exclusion criteria: 1.Untreated Hypothyroidism 2.Patients currently on SGLT2 inhibitors 3.History of Leprosy 4.Patients with current foot ulcer 5.Presence of Peripheral Vascular disease with critical limb ischemia (ABI 6.History of alcoholism ( >2 and >1 standard drink per day for male and female respectively) 7.Factors affecting corneal nerves (severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months) Negative consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate intraepithelial nerve fiber density(IENFD) at baseline and after 24 weeks of Dapagliflozin Timepoint: To evaluate intraepithelial nerve fiber density(IENFD) at baseline and after 24 weeks of Dapagliflozin | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate 1.Change in Nerve growth factor after 6 months of treatment 2.Effect of dapagliflozin on cardiac autonomic neuropathy (by Ewingââ?¬â?¢s criteria). 3. Corneal nerve fiber density (CNFD) after 6 months of dapagliflozinTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactUmanath Adhikari
Postgraduate Institute of Medical Education & Research
Outcome results
None listed