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

This trial does not accept healthy volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bariatric Sleeve Surgery

    Procedure/Surgery

    Participants 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

50 Participants
are divided into 2 treatment groups
Group A: Iron Deficiency Group1 intervention
Group B: Non-Iron Deficiency Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Measured at baseline (pre-surgery) and 6 months post-surgery.

Secondary outcomes

1

Percentage of total body fat

Measurement of total body fat percentage using Dual-Energy X-ray Absorptiometry (DEXA) scans.

Time frame
Baseline, 3 months, and 6 months after baseline visit.
2

Lean mass

Measurement of total lean body mass in kilograms using DEXA scans.

Time frame
Baseline, 3 months, and 6 months after baseline visit.
3

Bone mineral density

Measurement of bone mineral density using DEXA scans.

Time frame
Baseline, 3 months, and 6 months after baseline visit.
4

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.

Time frame
Baseline and 6 months after baseline visit.

Other outcomes

1

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.

Time frame
Baseline and 6 months post-baseline.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TecSalud Investigación Clínica

Lead sponsor

Fundación Santos y de la Garza Evia, IBP

Collaborator

This trial is not recruiting at the moment. You can still explore other options: