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Tytuł:
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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.
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Autorzy:
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Shivane V; Sadhana Diabesity Clinic, Prabhadevi, Mumbai, India. Electronic address: .
Pathak H; Seth G S Medical College & KEM Hospital, Mumbai, India. Electronic address: .
Tamoli S; Target Institute of Medical Education and Research, Mumbai, India. Electronic address: .
Kohli KR; Govt of Maharashtra, Mumbai, India. Electronic address: .
Ghungralekar R; Dept of Kayachikitsa, R A Podar Medical (Ayu) College, Mumbai, India. Electronic address: .
Deshmukh P; Research Methodology & Statistics, Sumatibhai Shah Hospital, Hadapsar, Pune, India. Electronic address: .
Hartalkar A; Sumatibhai Shah Hospital, Hadapsar, Pune, India. Electronic address: .
Mahadik S; Target Institute of Medical Education and Research, Mumbai, India. Electronic address: .
Indalkar P; Sadhana Diabesity Clinic, Prabhadevi, Mumbai, India. Electronic address: .
Mehta B; Aquatic Remedies, Mumbai, India. Electronic address: .
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Źródło:
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Diabetes & metabolic syndrome [Diabetes Metab Syndr] 2022 May; Vol. 16 (5), pp. 102483. Date of Electronic Publication: 2022 Apr 23.
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Typ publikacji:
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Journal Article; Multicenter Study; Randomized Controlled Trial
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Język:
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English
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Imprint Name(s):
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Original Publication: Amsterdam : Elsevier Ltd.
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MeSH Terms:
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Diabetes Mellitus, Type 2*/blood
Diabetes Mellitus, Type 2*/drug therapy
Diabetes Mellitus, Type 2*/therapy
Hypoglycemic Agents*/therapeutic use
Ultrasonic Therapy*
Adiponectin/blood ; Blood Glucose/metabolism ; Double-Blind Method ; Glycated Hemoglobin/metabolism ; Glycemic Control ; Humans ; Lipid Metabolism ; Quality of Life
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Contributed Indexing:
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Keywords: Airborne ultrasound; Glycemic control; Markers of inflammation; Type 2 diabetes
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Substance Nomenclature:
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0 (Adiponectin)
0 (Blood Glucose)
0 (Glycated Hemoglobin A)
0 (Hypoglycemic Agents)
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Entry Date(s):
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Date Created: 20220428 Date Completed: 20220614 Latest Revision: 20221207
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Update Code:
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20240104
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DOI:
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10.1016/j.dsx.2022.102483
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PMID:
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35483209
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Background and Aims: 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.
Competing Interests: Declaration of competing of interest None.
(Copyright © 2022 Diabetes India. Published by Elsevier Ltd. All rights reserved.)
