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| ID | Type | Description | Link |
|---|---|---|---|
| 539901_2019_Santini_PRIN2017 | Other Grant/Funding Number | Italian Ministry of the University |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antiobesity medication and energy expenditure | patients with obesity for the administration anti-obesity medication (Semaglutide or Tirzepatide) for the clinical use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti obesity medication | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in 24h energy expenditure after 6 months of treatment | measurement of 24-hour energy expenditure (kilocalories) by using the metabolic chamber (whole room indirect calorimeter) at baseline and after 6 months of treatment | Baseline and 6 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body composition | 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) | Baseline and 6 months after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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Adults aged 18-75 years with Body mass index (BMI) >= 30 kg/m² or >= 27 kg/m² with at least one weight-related comorbidity (e.g., prediabetes, hypertension, dyslipidemia, sleep apnea, cardiovascular disease) and stable body weight (±2 kg in prior 3 months)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| university hospital of Pisa | Pisa | Italy |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |