Comparison of statin monotherapy versus statin plus fenofibrate combination therapy on nerve conduction parameters in diabetic peripheral neuropathy with dyslipidemia in a tertiary care hospital: a randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
This pragmatic randomised controlled trial is meticulously designed to ascertain the effectiveness and safety of fenofibrate as an adjunct to standard of care in improving nerve conduction parameters for adults with early diabetic peripheral neuropathy and diabetic dyslipidemia. A core strength of this trial lies in its rigorous methodology, including a prospective, assessor-blind design, and the use of objective nerve conduction studies as primary and key secondary outcomes, allowing for a precise evaluation of intervention efficacy. The carefully defined inclusion and exclusion criteria, coupled with the glycemic stabilisation run-in phase, aim to ensure a relatively homogeneous study population, enhancing the internal validity of the findings. The study’s focus on a specific, high-risk subgroup (early DPN with dyslipidemia) addresses a critical unmet need for targeted interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 m²; 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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- • Change from baseline in peroneal NCV (in m/s) at 26 weeks, reflecting motor nerve fiber integrity.(Baseline and 26 weeks)
研究者
Dr Mohit Raj Singh
NH-Rabindranath Tagore International Institute of Cardiac Sciences