Efficacy of anti diabetic drug (Dapagliflozin) in patients with Diabetic periphral neuropathy
Phase 3
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2022/06/043236
- Lead Sponsor
- Postgraduate Institute of Medical Education Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <0.7 )
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate intraepithelial nerve fiber density(IENFD) at baseline and after 24 weeks of Dapagliflozin <br/ ><br>Timepoint: To evaluate intraepithelial nerve fiber density(IENFD) at baseline and after 24 weeks of Dapagliflozin <br/ ><br>
- Secondary Outcome Measures
Name Time Method To evaluate <br/ ><br>1.Change in Nerve growth factor after 6 months of treatment <br/ ><br>2.Effect of dapagliflozin on cardiac autonomic neuropathy (by Ewing�s criteria). <br/ ><br>3. Corneal nerve fiber density (CNFD) after 6 months of dapagliflozinTimepoint: 6 months