Iron Metabolism in Obesity

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorTecSalud Investigación Clínica

About this trial

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.

Eligibility criteria

Qualifiers

Male and female participants aged 18 to 50 years.

Premenopausal women (defined as no absence of menstruation in the past 12 months).

Body Mass Index (BMI) between 35 and 45 kg/m² at recruitment.

BMI between 35 and 45 kg/m² with the presence of obesity-related comorbidities (medical, physical, or psychosocial conditions), and a history of unsuccessful attempts at sustained weight loss through non-surgical means.

Disqualifiers

Participants who have undergone any bariatric procedure other than LAGB or sleeve gastrectomy.

Severe anemia (defined as hemoglobin <100 g/L).

History of previous surgical obesity treatments.

Presence of significant medical conditions that may affect iron status or inflammatory markers independently of obesity, including but not limited to: cancer, HIV/AIDS, inflammatory bowel disease, gastrointestinal bleeding, rheumatoid arthritis, and chronic kidney disease (per investigator's judgment).

Trial design

Treatments tested in this trial

  • Bariatric Sleeve Surgery

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

TecSalud Investigación Clínica

Lead sponsor

Fundación Santos y de la Garza Evia, IBP

Collaborator