Effect of heart rate variability biofeedback training on peripheral sensory status and cardiac autonomic status in type 2 diabetes mellitus
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AIIMS
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Change in heart rate variability (time and frequency domain)
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is a metabolic disorder characterized by high blood sugar levels due to insulin resistance when the body cannot fully respond to insulin. Diabetic neuropathy is traditionally considered a common complication of diabetes which can present in the form of distal symmetrical polyneuropathy (DSPN) and cardiac autonomic neuropathy (CAN). Distal symmetrical polyneuropathyaffects up to 50% of adults with long-term diabetes. Quantitative sensory testing (QST) is a non-invasive tool in which standardized testing procedures allow the quantification of somatosensory functions. Very few studies have quantified peripheral neuropathic status in T2DM using QST but all have reported dysfunction in T2DM. The overall prevalence of cardiac autonomic neuropathy among patients with T2DM is approximately 20 - 73%. It is characterized by impairment of the parasympathetic and sympathetic components of the autonomic nervous system. CAN is a significant cause of morbidity and mortality associated with a high risk of cardiac arrhythmias and sudden death. Heart rate variability (HRV) is a simple non-invasive tool commonly employed to evaluate cardiac autonomic status. A high rate of neuropathic complications indicates the need for investigation into new therapeutic modalities. Heart rate variability biofeedback (HRVB) training is a non-invasive tool that has been shown to be an effective adjunct to standard therapy in various disorders. Very few studies have investigated the effects of HRVB in T2DM patients. Furthermore, no information from any randomized controlled trial for the same is available. Therefore, the present randomized controlled trial is planned to study the effect of HRVB training on the peripheral sensory and cardiac autonomic neurological profile in patients of T2DM.
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
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Age: 18-50 years 2 Type 2 diabetes mellitus.
排除标准
- •1 Neuropathic pain due to causes other than diabetes 2 Central nervous system lesions 3 History indicating a disease, condition, or treatment that might be a potential cause of polyneuropathy other than diabetes 4 Blunted response to deep breathing test with delta heart rate less than 5 during deep breathing 5 Yogic breathing or meditation practitioners practicing supervised or unsupervised sessions one or more than once per week in the last 6 months.
结局指标
主要结局
1. Change in heart rate variability (time and frequency domain)
时间窗: At the end of 4 weeks of heart rate variability biofeedback training.
2. Change in peripheral sensory profile (Quantitative sensory testing)
时间窗: At the end of 4 weeks of heart rate variability biofeedback training.
3. Change in glycemic status (Fasting blood glucose, HbA1c)
时间窗: At the end of 4 weeks of heart rate variability biofeedback training.
次要结局
- 1. Change in heart rate variability (time & frequency domain)(2. Change in peripheral sensory profile (Quantitative sensory testing))
