Dataset Information

Cryolipolysis-induced abdominal fat change: Split-body trials.

ABSTRACT: Cryolipolysis has been considered as a noninvasive alternative to surgical procedures for reducing subcutaneous fat without affecting the surrounding tissues. However, no clinical trial has investigated changes in the abdominal fat tissue by 12 weeks after cryolipolysis. Therefore, in this split-body trial, we explored whether a single session of unilateral cryolipolysis could change visceral and subcutaneous adipose tissue over a period of 12 weeks. We compared the cross-sectional areas of the abdominal adipose tissue of 15 subjects (9 women; 38.3 [10.8] years) by computed tomography before and at 12 weeks after a single treatment of cryolipolysis to the left abdomen and used the right abdomen as untreated control. In addition, we measured participants' waist circumference, percentage of body fat (by bioelectrical impedance analysis) at baseline and at 6- and 12-weeks post-treatment. Single unilateral cryolipolysis tended to reduce the cross-sectional areas of visceral adipose tissue, by 8.4 cm2 (9.9%), the waist circumferences, and the percent body fat, by 2.8 cm2 (0.6%), overall. The cross-sectional area of visceral adipose tissues on the treated side significantly decreased, by 6.8 cm2 (15.6%; P = 0.003), and that of the untreated side tended to decrease by 1.2 cm2 (3.6%). Thus, a single unilateral session of noninvasive selective cryolipolysis can be considered as a safe and effective treatment for reduction of visceral adipose tissue over a period of 12 weeks, which should result in metabolic improvement.

SUBMITTER: Hwang IC

PROVIDER: S-EPMC7771684 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Cryolipolysis-induced abdominal fat change: Split-body trials.

Hwang In Cheol IC Kim Kyoung Kon KK Lee Kyu Rae KR

PloS one 20201229 12

Cryolipolysis has been considered as a noninvasive alternative to surgical procedures for reducing subcutaneous fat without affecting the surrounding tissues. However, no clinical trial has investigated changes in the abdominal fat tissue by 12 weeks after cryolipolysis. Therefore, in this split-body trial, we explored whether a single session of unilateral cryolipolysis could change visceral and subcutaneous adipose tissue over a period of 12 weeks. We compared the cross-sectional areas of the ...[more]

PMID: 33373395

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Project description:Cryolipolysis has previously received FDA clearance for fat reduction in the abdomen, flanks, and thighs. There is also interest in small volume fat reduction for areas such as the chin, knees, and axilla. This article reports the results of a cryolipolysis pivotal IDE study for reduction of submental fullness.A prototype small volume vacuum applicator (CoolMini applicator, CoolSculpting System, ZELTIQ Aesthetics) was used to treat 60 subjects in the submental area. At each treatment visit, a single treatment cycle was delivered at -10°C for 60 minutes, the same temperature and duration used in current commercially-available cryolipolysis vacuum applicators. At the investigator's discretion, an optional second treatment was delivered 6 weeks after the initial treatment. The primary efficacy endpoint was 80% correct identification of baseline photographs by independent physician review. The primary safety endpoint was monitoring incidence of device- and/or procedure-related serious adverse events. Secondary endpoints included assessment of fat layer thickness by ultrasound and subject satisfaction surveys administered 12 weeks after final cryolipolysis treatment.Independent photo review from 3 blinded physicians found 91% correct identification of baseline clinical photographs. Ultrasound data indicated mean fat layer reduction of 2.0?mm. Patient questionnaires revealed 83% of subjects were satisfied, 80% would recommend submental cryolipolysis to a friend, 77% reported visible fat reduction, 77% felt that their appearance improved following the treatment, and 76% found the procedure to be comfortable. No device- or procedure-related serious adverse events were reported.The results of this clinical evaluation of 60 patients treated in a pivotal IDE study demonstrate that submental fat can be reduced safely and effectively with a small volume cryolipolysis applicator. Patient surveys revealed that submental cryolipolysis was well-tolerated, produced visible improvement in the neck contour, and generated high patient satisfaction. These study results led to FDA clearance of cryolipolysis for submental fat treatment.

Project description:Tetrahydrobiopterin (BH4) is an essential cofactor for several metabolic enzymes, including the aromatic amino acid hydroxylases, alkylglycerol mono-oxygenase and NO synthases. BH4 deficiency due to an autosomal recessive defect in its biosynthetic enzyme 6-pyruvoyltetrahydropterin synthase (PTPS, encoded by the PTS gene) leads to a variant form of hyperphenylalaninemia concomitant with severe deficiency of brain monoamine neurotransmitters. In contrast, augmentation of BH4 by pharmacological supplementation or stimulation of its biosynthesis is thought to correct eNOS dysfunction, to protect from (cardio) vascular disease and/or to prevent from abdominal obesity and development of the metabolic syndrome. We have previously reported that complete Pts knock-out (ko) mice die after birth (Elzaouk et al JBC 2003). Here we generated a murine Pts-knock-in (ki) allele expressing a PTPS-p.Arg15Cys mutant enzyme with low residual activity (12% of wild-type in vitro) and investigated heterozygous Pts-ko/wt, homozygous Pts-ki/ki and compound heterozygous Pts-ki/ko mutant mice. All mice were viable and, depending on the severity of the Pts alleles, exhibited up to 90% reduction of PTPS activity in liver and brain tissues concomitant with high neopterin, but neither an elevation of blood L-Phe, nor a decrease in brain monoamine neurotransmitters dopamine or serotonin. Upon a standard systemic and comprehensive phenotyping of Pts-ki/ki mice, we found alterations in energy metabolites with reduced body mass, higher fat content, lower lean mass, and increased blood glucose and cholesterol in mutant animals. Furthermore, heterozygous Pts-ko/wt and/or homozygous Pts-ki/ki mice exhibited increased body weight and elevated intra-abdominal fat tissue when fed with normal chow or high fat diet. We conclude that a reduced BH4-biosynthetic activity in mice leads to abnormal body fat distribution and abdominal obesity potentially through a mildly compromised eNOS function.

Dataset Information

Cryolipolysis-induced abdominal fat change: Split-body trials.

Publications

Cryolipolysis-induced abdominal fat change: Split-body trials.

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