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
This trial does not accept healthy volunteersQualifiers
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 population
The study population consists of obese adults scheduled for restrictive sleeve bariatric surgery residing in the urban area of Monterrey, Mexico, who voluntarily agree to participate in the study over a 6-month follow-up period.
Trial design
Cohort
Prospective
Treatments tested in this trial
Bariatric Sleeve Surgery
Procedure/SurgeryParticipants undergo a restrictive bariatric procedure called sleeve gastrectomy, performed by experienced surgeons. This procedure involves surgical reduction of the stomach size to aid in weight loss. The study observes outcomes related to iron metabolism, body composition, and biochemical markers over six months post-surgery. No additional interventions or treatments are applied as part of the study protocol; the surgery is part of routine clinical care.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Body Weight Loss at 6 Months Post-Surgery
Proportion of initial body weight lost by each participant, calculated as ((initial weight - weight at 6 months) / initial weight) × 100. This measure is used to assess the effectiveness of bariatric sleeve surgery and to evaluate differences between participants with and without iron deficiency.
Secondary outcomes
Percentage of total body fat
Measurement of total body fat percentage using Dual-Energy X-ray Absorptiometry (DEXA) scans.
Lean mass
Measurement of total lean body mass in kilograms using DEXA scans.
Bone mineral density
Measurement of bone mineral density using DEXA scans.
Changes in gut microbiota composition
Analysis of fecal samples by 16S rDNA sequencing to evaluate changes in gut microbiota diversity and composition at baseline and 6 months post-surgery.
Other outcomes
Quality of life evaluation using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10-item questionnaire
Assessment of general health, mental health, fatigue, pain, and functionality using the PROMIS Global Health 10-item questionnaire. Each item is scored on a 1-5 Likert scale, with higher scores indicating better health status. Raw scores are converted to standardized T-scores, which range from 0 to 100. For all domains, higher scores represent a better outcome.
Sponsors and contacts
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TecSalud Investigación Clínica
Lead sponsor
Fundación Santos y de la Garza Evia, IBP
Collaborator
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