Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Fenofibrate: Fenofibrate 160mg daily in addition to Standard of care(SOC) for 26 weeks
Control Intervention1: Standard Of Care: SOC mainly comprised of rosuvastatin 10mg,up-titrated to
Sponsors
Dr Mohit Raj Singh
Eligibility
Inclusion criteria
Inclusion criteria: Age between 40 to 65 years old; established diagnosis of Type 2 Diabetes Mellitus according to the American Diabetes Association (ADA) criteria; diagnosis of Early Diabetic Peripheral Neuropathy (DPN) evidenced by the presence of sensory neuropathic symptoms (e.g., pain, paresthesia, numbness) in the lower extremities and an mTCNS score of 1 to 11, indicating minimal-to-moderate evidence of DPN; diabetic dyslipidemia defined as Triglycerides more than or equal to 150 mg/dL and HDL-C less than 40 mg/dL for men or less than 50 mg/dL for women; glycemic control with HbA1c less than or equal to 10%; and willingness and ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Presence of other known causes of peripheral neuropathy (e.g., vitamin B12 deficiency, alcohol abuse, chemotherapy-induced neuropathy, autoimmune neuropathy, radiculopathy); 2) a modified TCNS score more than 11, indicative of severe neuropathy; abnormal nerve conduction studies (NCS) suggestive of predominantly demyelinating neuropathy or other changes not consistent with typical DPN; 3) very high triglyceride levels mandating fenofibrate in the comparator arm (Triglyceride more than 1000 mg/dL or whenever deemed appropriate by the investigator); 4) an estimated glomerular filtration rate (eGFR) less than 30 mL per min per 1.73 m ; 5) previous history of myopathy or rhabdomyolysis; 6) use of medications known to affect nerve function (e.g., certain chemotherapeutic agents, amiodarone) or serum triglycerides (e.g., other fibrates, high-dose niacin, omega-3 fatty acids at high doses) within 3 months prior to screening; 7) uncontrolled hypothyroidism; 8) pregnancy or breastfeeding; 9) active cancer requiring treatment; 10) a history of major cardiovascular event (e.g., myocardial infarction, stroke) within the past 6 months; or any other condition that would interfere with the ability of participants to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the change from baseline in Sural nerve conduction velocity (NCV) at 26 weeks, defined as the between-group difference in mean changes of meters per second (m/s). This objective measure will be assessed using standardised nerve conduction studies, ensuring consistent procedures are followed for all measurements.Timepoint: The primary outcome measure is the change from baseline in Sural nerve conduction velocity (NCV) at Baseline(Zero weeks ) and 26 weeks, defined as the between-group difference in mean changes of meters per second (m/s). This objective measure will be assessed using standardised nerve conduction studies, ensuring consistent procedures are followed for all measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in peroneal NCV (in m/s) at 26 weeks, reflecting motor nerve fiber integrity.Timepoint: Baseline and 26 weeks | — |
Countries
India
Contacts
Public ContactDr Mainak Banerjee
NH-Rabindranath Tagore International Institute of Cardiac Sciences
Outcome results
None listed