Obesity
Conditions
Keywords
energy metabolism, body composition
Brief summary
This study investigates the long-term effects of anti-obesity medications (Semaglutide and Tirzepatide) on energy metabolism (24-hour energy expenditure and substrate oxidation) and body composition via Dual-energy X-ray absorptiometry (DXA)
Detailed description
This study will explore the long-term effects of obesity treatments, including anti-obesity medications (AOMs) such as GLP-1 receptor agonist (Semaglutide) and GIP/GLP-1 receptor agonist (Tirzepatide), on energy metabolism (24-hour energy expenditure and substrate oxidation), body composition (fat mass and fat-free mass). The study will include AOMs may lead to a state of metabolic adaptation, one of the reasons for weight regain. To date, no studies have assessed the effects of AOMs on 24-hour energy expenditure measured by using the metabolic chamber.
Interventions
DRUGanti obesity medication
Patients with obesity or overweight, with at least one weight-related comorbidity who are expected to start treatment with Semaglutide (Wegovy) or Terzepatide (Mounjaro) at enrolment will be eligible to enrol into the study. Patients will be treated and observed according to normal clinical practice. Participation in this study does not limit the physicians' clinical decision making as to the most appropriate treatment for the patient during the course of the study
Sponsors
University of Pisa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) \>= 30 kg/m² or \>= 27 kg/m² with at least one weight-related comorbidity and stable body weight (±2 kg in prior 3 months) * informed consent, adherence to study protocol, negative pregnancy test and contraception use (if applicable), and absence of cardiovascular events or end-organ damage.
Exclusion criteria
* psychiatric conditions impairing adherence, history of medullary thyroid cancer, pregnancy/lactation * diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in 24h energy expenditure after 6 months of treatment | Baseline and 6 months after treatment initiation | measurement of 24-hour energy expenditure (kilocalories) by using the metabolic chamber (whole room indirect calorimeter) at baseline and after 6 months of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition | Baseline and 6 months after treatment initiation | Quantification of variations in fat mass and fat-free mass (kg) following 6 months of therapy, as determined by Dual-Energy X-ray Absorptiometry (DEXA) |
Countries
Italy
Outcome results
None listed