24-h Energy Expenditure and Anti-obesity Medication

NCT ID: NCT07041983

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-01

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.

Conditions

Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

antiobesity medication and energy expenditure

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

anti obesity medication

Intervention Type: 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

Interventions

anti 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pisa

OTHER

Sponsor Role: lead

Responsible Party

Alessio Basolo

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

539901_2019_Santini_PRIN2017

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SEM-TIR

Identifier Type: -

Identifier Source: org_study_id