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临床试验/NCT07041983
NCT07041983尚未招募不适用

Effects of Anti-obesity Medications on 24h Energy Metabolism and Body Composition in Patients With Obesity

University of Pisa1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
change in 24h energy expenditure after 6 months of treatment

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • psychiatric conditions impairing adherence, history of medullary thyroid cancer, pregnancy/lactation

研究组 & 干预措施

antiobesity medication and energy expenditure

patients with obesity for the administration anti-obesity medication (Semaglutide or Tirzepatide) for the clinical use.

干预措施: anti obesity medication (Drug)

结局指标

主要结局

change in 24h energy expenditure after 6 months of treatment

时间窗: 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

次要结局

  • Change in body composition(Baseline and 6 months after treatment initiation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessio Basolo

Researcher

University of Pisa

研究点 (1)

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