Efficacy of Epalrestat and Benfotiamine in Reducing Nerve Damage in Patients with Diabetes Mellitus (Type 2 Diabetes)

Not yet recruiting

Conditions: Diabetic Neuropathy

Registration Number: CTRI/2017/08/009577

Lead Sponsor: JIPMER Intramural fund

Brief Summary: Diabetic neuropathy is one of the most common complications of diabetes and causes maximum morbidity to the patients. The prevalence of diabetic neuropathy varies between 10-90%. The risk increases with duration of diabetes. There is a huge economic burden which is caused both to the patients and the health care sector due to irreversible diabetic neuropathy. Hence early diagnosis and management is imperative in the improvement of quality of life of the patients failing which serious consequences including disability and amputation can occur.The current treatment of diabetic neuropathy is purely symptomatic and does not stop the progression of the disease. Hence research has been undertaken in the development of disease modifying agents. Epalrestat which is an aldose reductase inhibitor can inhibit the polyol pathway and benfotiamine which is a thiamine analog can inhibit the formation of advanced glycation end products and combat oxidative stress. These drugs may be used as disease modifying agents in the treatment of diabetic neuropathy if given at an early stage, before irreversible damage sets in. Studies have shown the beneficial effect of these drugs in diabetic neuropathy. But the superiority of one over the other is not yet investigated. The results of this trial may establish the superiority of one of the drug over the

other in the treatment of diabetic neuropathy. If the treatment is initiated at an early stage it can reverse the pathology, reduce the morbidity caused due to diabetic neuropathy and improve the quality of life in these patients.

**Research Question:**

Is three months of therapy with epalrestat more efficacious than benfotiamine in the treatment of diabetic neuropathy in patients with type 2 diabetes mellitus?

**Research Hypothesis:**

Three months of therapy with epalrestat is more efficacious than benfotiamine in the treatment of diabetic neuropathy in patients with type 2 diabetes mellitus.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

Patients with type 2 diabetes mellitus presenting to the diabetology clinic of Medicine outpatient department (OPD) diagnosed to have diabetic neuropathy with symptoms of paresthesia, dysesthesia, numbness, hypoesthesia (but not anesthesia).

Exclusion Criteria

Patients with peripheral vascular diseases 2.
Patients taking Vitamin B12, Vitamin B6, alpha lipoic acid, gabapentin, pregabalin, duloxetine and amitryptiline.
Patients with renal and hepatic dysfunction and congestive cardiac failure 4.
Patients without reasonably good levels of HbA1c(>8.5).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Motor nerve conduction velocity in median and common peroneal nerves	1.Baseline, 3rd month end \| 2.Baseline, 3rd month end
1.Sensory nerve conduction velocity in median and sural nerves	1.Baseline, 3rd month end \| 2.Baseline, 3rd month end

Secondary Outcome Measures

Name	Time	Method
1. Sensory Nerve Action Potential (SNAP) - Median and Sural nerves	2. F Wave Latency (FWL) - Median and Common Peroneal nerves

Trial Locations

Locations (1): JIPMER hospital
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER hospital
🇮🇳Pondicherry, PONDICHERRY, India
Dr B Priyadarsini
Principal investigator
9790820215
priya3491@gmail.com