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Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study

RecruitingNAAges 25 Years - 50 YearsAllNational Medical Research Center for Therapy and โ€ฆ
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In plain words

What the trial is, and whether it could suit you

This single-center randomized comparative study is designed to compare the effectiveness of tirzepatide and transcutaneous low-frequency auricular vagus nerve stimulation in adults with class I obesity and without chronic non-communicable diseases. The study focuses on changes in body weight, anthropometric indices, epicardial and visceral adipose tissue, body composition, behavioral factors, skeletal muscle characteristics, and cardiac structure and function. The study will include 120 participants. The active-treatment cohort will comprise 60 adults aged 25 to 50 years with class I obesity and low cardiovascular risk. These participants will be assigned to two active-treatment groups: 30 participants will receive tirzepatide (Tirzetta), and 30 participants will receive transcutaneous auricular vagus nerve stimulation using the HEALBE NEEM device. A control cohort of 60 participants wi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age 25 to 50 years. * Low cardiovascular risk according to the SCORE scale (SCORE \<1%). * Written informed consent to participate in the study Exclusion Criteria: * Cardiac rhythm disorders, including bradyarrhythmias and atrioventricular block of any degree. * For participants in the obesity cohorts: body mass index greater than or equal to 35 kg/mยฒ. Participants with normal body weight may be enrolled in the designated normal-weight control subgroup. * Expected technical difficulties with use of the stimulation device by the participant. * Any acute disease or chronic disease in the stage of exacerbation and/or decompensation.
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What it tests

  • Tirzepatide
  • Transcutaneous auricular vagus nerve stimulation
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Where

1 site
National Medical Research Center for Therapy and Preventive Medicine
Moscow, Russia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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