Abstract：
OBJECTIVE: Airborne Low Intensity Multi frequency Ultrasound (ALIMFUS) uses thermal and non thermal principal of ultrasound to facilitate transportation of drugs into the cells and it\'s metabolism. This is randomized, multi-center, Double Blind, Interventional, Placebo Controlled Study to evaluate efficacy and safety of ALIMFUS as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type 2 DM.
METHODS: Total 103/186 subjects completed the study and received 10 min either ALIMFUS therapy on alternate day for 90 days or placebo. Baseline and end of the study Lab parameters like HbA1c, blood sugars, Lipid Profile, Serum Hs-CRP, Serum Interleukin-6, Serum TNF-α, Serum homocysteine, Serum Vitamin D, Serum Leptin, Serum Adiponectin and Quality of Life score were assessed.
RESULTS: At the end of study ALIMFUS group achieved greater (0.77 ± 1.13 vs 0.48 ± 0.79) but non-significant reduction in HbA1c. More subjects in ALIMFUS group (30.76% vs 27.45%) achieved HbA1c < 7%. Significant reduction in fasting and postprandial glucose noted in both groups whose baseline HbA1c was ≥8%. Significant reduction in lipid profile noted in ALIMFUS group compared to placebo. Insulin, adiponectin, CRP and homocysteine and quality of life were significantly better in ALMFUS group compared to baseline; but non-significant compared to placebo. No adverse events were associated with ALIMFUS.
CONCLUSIONS: Thus, ALIMFUS could be novel technology in diabetes management for patient unable to achieve glycemic targets on combination therapy. However further exploratory long term studies are required to demonstrate its effective role as add-on therapy in diabetes management.
METHODS: Total 103/186 subjects completed the study and received 10 min either ALIMFUS therapy on alternate day for 90 days or placebo. Baseline and end of the study Lab parameters like HbA1c, blood sugars, Lipid Profile, Serum Hs-CRP, Serum Interleukin-6, Serum TNF-α, Serum homocysteine, Serum Vitamin D, Serum Leptin, Serum Adiponectin and Quality of Life score were assessed.
RESULTS: At the end of study ALIMFUS group achieved greater (0.77 ± 1.13 vs 0.48 ± 0.79) but non-significant reduction in HbA1c. More subjects in ALIMFUS group (30.76% vs 27.45%) achieved HbA1c < 7%. Significant reduction in fasting and postprandial glucose noted in both groups whose baseline HbA1c was ≥8%. Significant reduction in lipid profile noted in ALIMFUS group compared to placebo. Insulin, adiponectin, CRP and homocysteine and quality of life were significantly better in ALMFUS group compared to baseline; but non-significant compared to placebo. No adverse events were associated with ALIMFUS.
CONCLUSIONS: Thus, ALIMFUS could be novel technology in diabetes management for patient unable to achieve glycemic targets on combination therapy. However further exploratory long term studies are required to demonstrate its effective role as add-on therapy in diabetes management.
摘要：
目的：机载低强度多频超声（ALIMFUS）利用超声的热和非热原理来促进药物进入细胞及其代谢。这是随机的，多中心,双盲,介入性,安慰剂对照研究，以评估ALIMFUS作为2型DM口服降糖药（OHA）的附加疗法的疗效和安全性。
方法：总共103/186名受试者完成了研究，并接受了10分钟的ALIMFUS治疗90天或安慰剂。基线和研究结束实验室参数，如HbA1c，血糖，脂质分布,血清Hs-CRP,血清白细胞介素-6,血清肿瘤坏死因子-α,血清同型半胱氨酸,血清维生素D,血清瘦素,评估血清脂联素和生活质量评分。
结果：在研究结束时，ALIMFUS组取得了更高的疗效（0.77±1.13vs0.48±0.79），但HbA1c没有显著降低。ALIMFUS组中更多的受试者（30.76％vs27.45％）达到HbA1c<7％。在基线HbA1c≥8％的两组中，空腹和餐后血糖均显着降低。与安慰剂相比,在ALIMFUS组中注意到脂质分布的显著降低。胰岛素,脂联素,与基线相比，ALMFUS组的CRP和同型半胱氨酸和生活质量明显更好；但与安慰剂相比无统计学意义。无与ALIMFUS相关的不良事件。
结论：因此，ALIMFUS可能是糖尿病管理的新技术，用于无法实现联合治疗的血糖目标的患者。然而，需要进一步的探索性长期研究来证明其在糖尿病管理中作为附加疗法的有效作用。
方法：总共103/186名受试者完成了研究，并接受了10分钟的ALIMFUS治疗90天或安慰剂。基线和研究结束实验室参数，如HbA1c，血糖，脂质分布,血清Hs-CRP,血清白细胞介素-6,血清肿瘤坏死因子-α,血清同型半胱氨酸,血清维生素D,血清瘦素,评估血清脂联素和生活质量评分。
结果：在研究结束时，ALIMFUS组取得了更高的疗效（0.77±1.13vs0.48±0.79），但HbA1c没有显著降低。ALIMFUS组中更多的受试者（30.76％vs27.45％）达到HbA1c<7％。在基线HbA1c≥8％的两组中，空腹和餐后血糖均显着降低。与安慰剂相比,在ALIMFUS组中注意到脂质分布的显著降低。胰岛素,脂联素,与基线相比，ALMFUS组的CRP和同型半胱氨酸和生活质量明显更好；但与安慰剂相比无统计学意义。无与ALIMFUS相关的不良事件。
结论：因此，ALIMFUS可能是糖尿病管理的新技术，用于无法实现联合治疗的血糖目标的患者。然而，需要进一步的探索性长期研究来证明其在糖尿病管理中作为附加疗法的有效作用。
