24-h Energy Expenditure and Anti-obesity Medication

NCT07041983 | Enrolling By Invitation

• 2 other identifiers: SEM-TIR539901_2019_Santini_PRIN2017
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Conditions

Obesity

Keywords

energy metabolism; body composition

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in body composition

  Baseline and 6 months after treatment initiation

Study Arms (1)

antiobesity medication and energy expenditure

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

Drug: anti obesity medication

Interventions

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

antiobesity medication and energy expenditure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

university hospital of Pisa

Pisa, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-06

Locations

IT (1)