No phaseRecruiting
Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study (TIFFANY)
- Sponsor
- National Medical Research Center for Therapy and Preventive Medicine (Government)
- Enrolment
- 120 planned
- Conditions
- Class I Obesity
- Interventions
- Tirzepatide; Transcutaneous auricular vagus nerve stimulation
- Ages
- adults
- Registry
- NCT07866183
Full record on ClinicalTrials.gov
From the registry
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 will include 30 individuals with normal body weight and 30 individuals with class I obesity who will not receive either study intervention. Follow-up assessments will be conducted at Weeks 8, 16, and…
Primary outcomes
- Percentage reduction in body weight
- Percentage reduction in waist-to-height ratio
- Percentage reduction in epicardial adipose tissue thickness
- Percentage reduction in visceral adipose tissue
History
Study completion expected
Primary completion expected
Registered
Started