Effect of Airborne Low Intensity Multi frequency ultrasound (ALIMFUS) on glycemic control, lipid profile and markers of inflammation in patients with uncontrolled type 2 diabetes: A multicentre proof of concept, randomized double blind Placebo controlled study

Effect of Airborne Low Intensity Multi frequency ultrasound (ALIMFUS) on glycemic control, lipid profile and markers of inflammation in patients with uncontrolled type 2 diabetes: A multicentre proof of concept, randomized double blind Placebo controlled study

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 efficac...

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Published in:Diabetes & metabolic syndrome clinical research & reviews Vol. 16; no. 5; p. 102483
Main Authors: Shivane, Vyankatesh, Pathak, Harish, Tamoli, Sanjay, Kohli, K.R., Ghungralekar, Raman, Deshmukh, Pranita, Hartalkar, Amol, Mahadik, Swapnali, Indalkar, Pradeep, Mehta, Bharat
Format: Journal Article
Language:English
Published: Netherlands Elsevier Ltd 01-05-2022
Subjects:
Airborne ultrasound
Glycemic control
Markers of inflammation
Type 2 diabetes
Type 2 diabetes
Airborne ultrasound
Glycemic control
Markers of inflammation
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Summary: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. 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. 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. 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. •Ultrasound has been shown to be effective in the delivery of drugs for a variety of purposes.•In uncontrolled Type 2DM patients, ALIMFUS demonstrated a non-significant decrease in HbA1c.•In uncontrolled diabetics, ALIMFUS, showed a significant decrease in lipid parameters, fasting and postprandial glucose.•In uncontrolled Type 2DM patients, ALIMFUS showed significant improvement in biomarkers compared to baseline.
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ISSN:1871-4021
1878-0334
DOI:10.1016/j.dsx.2022.102483