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IRCT20181010041303N1 IRCT 2020-11-15 Mashhad University of Medical Sciences Effect of microwaves platform on reduction of abdominal subcutaneous fat Effect of microwaves platform on reduction of abdominal subcutaneous fat and plasma leptin and adiponectin level. 2020-10-27 anticipated 30 Complete https://irct.ir/trial/51859 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 overweight. Intervention group:According to the standard treatment protocol, patients are treated with microwave technology (2.5 GHz radiofrequency) using Onda device (Onda, DEKA technology, Florence, Italy) for 3 sessions with an interval of 20 days. Participants are also given an isocaloric diet. This process is repeated in the second session of the treatment intervention (20 days after the first session) and also 20 days after the second and third intervention.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Because the study is not over yet and we do not know the available information, we have not yet decided how to publish the data.
public Abdolreza Norouzy
School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 0071151303 +98 51 3882 7034 norouzya@mums.ac.ir Mashhad University of Medical Sciences scientific Abdolreza
School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 0071151303 +98 51 3882 7034 norouzya@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Healthy people aged 18 to 65 years overweight with a body mass index (BMI) of less than 30 kg / m2 Intra-abdominal fat volume less than 12 kg Absence of active cancer (chemotherapy / radiotherapy) in the last 6 months No non-invasive lipolysis in the abdomen or other parts of the body in the last 3 months completing a moral consent or no legal prohibition on intervention Absence of abdominal surgery in the last 6 months Absence of acute heart disease in the last 6 months Absence of liver cirrhosis in the last 6 months 18 years 65 years Both Pregnancy and lactation Use of anticoagulants (other than aspirin) Use of isotretinoin drugs Secretion skin lesions and active eczema on the surface of the abdominal skin E66.3 Overweight Treatment - Devices Intervention group:According to the standard treatment protocol, patients are treated with microwave technology (2.5 GHz radiofrequency) using Onda device (Onda, DEKA technology, Florence, Italy) for 3 sessions with an interval of 20 days. Participants are also given an isocaloric diet. This process is repeated in the second session of the treatment intervention (20 days after the first session) and also 20 days after the second and third intervention. Body mass index: ratio of weight (kg) to height2 (m2). Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: Using the formula weight (kg)/ height 2 (m2). Percentage of body fat. Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: with body analyzer. Waist circumference. Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: Using a tape measure. The thickness of the subcutaneous fat tissue of the abdomen. Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: By ultrasound device. Intra-abdominal adipose tissue volume. Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: By ultrasound device. Serum levels of adiponectin. Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: ELISA kit. Serum levels of lipoprotein lipase. Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: ELISA kit. Prooxidane-Antioxidant Balance (PAB). Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: By calorimetric method. Serum levels of leptin. Timepoint: At the beginning of the study (before the intervention) and 20, 40 and 60 days after the start. Method of measurement: ELISA kit. Daily calorie intake. Timepoint: baseline. Method of measurement: food frequency questionnaire. Daily physical activity. Timepoint: baseline. Method of measurement: IPAQ questionnaire. Artiman Approved 2020-10-26 Ethics committee of Mashhad University of Medical Sciences School of Medicine, east door of the university campus, Azadi Square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)