Clinical Trial

Iron Metabolism in Obesity

Study acronym: IRON-XL
Not Yet Recruiting
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Record status
This record was last updated September 5, 2025 (before its estimated November 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study consists of two phases and aims to understand how obesity and systemic iron deficiency affect iron accumulation in important organs such as the liver and heart, as well as oxidative stress in fat tissue cells. In Phase 1, researchers will compare individuals with obesity who have iron deficiency to those without, to see if there are differences in the amount of iron stored in the liver and heart, measured by magnetic resonance imaging (MRI), and in oxidative stress and labile iron in visceral and subcutaneous fat tissue, assessed through biopsies. Phase 2 is a six-month prospective cohort study following the same individuals after they undergo bariatric surgery, a weight-loss surgery. The goal is to evaluate whether weight and fat loss normalize iron accumulation in the liver and heart, reduce oxidative stress, improve systemic iron metabolism, enhance blood sugar control, support liver function, modulate chronic inflammation, and restore gut microbiota diversity. Researchers will compare these health changes between individuals with and without iron deficiency. The study includes adults aged 18 to 50 with obesity living in the metropolitan area of Monterrey, Mexico, who are scheduled for laparoscopic sleeve gastrectomy surgery and agree to participate. The findings could improve understanding of how iron metabolism interacts with obesity-related complications and may lead to better treatments and management strategies for people with obesity and iron deficiency.
Trial Details
NCT Number NCT07157332
Lead Sponsor TecSalud Investigación Clínica
Collaborators: Fundación Santos y de la Garza Evia, IBP
Conditions Obesity (Disorder)
Enrollment 50 participants
Start Date 2025-09-15
Primary Completion 2025-11-15 (estimated)
Study Completion 2027-08-15 (estimated)
Updated on ClinicalTrials.gov 2025-09-05