Iron Metabolism in Obesity

NCT07157332 | Not Yet Recruiting

• 1 other identifier: IPI-D
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity (Disorder)

Keywords

Obesity; Weight loss; Iron metabolism; Metabolic health; Bariatric surgery; Body composition; Inflammation markers; Dietary assessment

Outcome Measures

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.

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

Secondary Outcomes (18)

• Percentage of total body fat

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

• Lean mass

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

• Bone mineral density

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

• Changes in gut microbiota composition

  Baseline and 6 months after baseline visit.

• Blood pressure

  At baseline, 1 month, 3 months, and 6 months post-baseline.

Other Outcomes (1)

• Quality of life evaluation using the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10-item questionnaire

  Baseline and 6 months post-baseline.

Study Arms (2)

Iron Deficiency Group

Participants with obesity who meet the World Health Organization criteria for systemic iron deficiency, defined as serum ferritin \< 15 µg/L or \< 70 µg/L in presence of inflammation, and/or elevated transferrin receptor levels (\>8.2 µg/L). These participants undergo bariatric surgery and are followed prospectively for changes in iron metabolism, oxidative stress, inflammation, and metabolic health.

Procedure: Bariatric Sleeve Surgery

Non-Iron Deficiency Group

Participants with obesity without systemic iron deficiency according to WHO standards, with normal serum ferritin and transferrin receptor levels. They undergo bariatric surgery and are followed in parallel to the iron deficiency group to compare outcomes in iron metabolism, oxidative stress, inflammation, and metabolic health over 6 months post-surgery.

Procedure: Bariatric Sleeve Surgery

Interventions

Bariatric Sleeve Surgery PROCEDURE

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.

Also known as: Sleeve Gastrectomy

Iron Deficiency Group; Non-Iron Deficiency Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• Scheduled to undergo bariatric surgery via sleeve gastrectomy or laparoscopic adjustable gastric banding (LAGB), with indications aligned with international guidelines. Bariatric surgery eligibility includes:
• 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.
• Adequately informed, understanding and accepting the potential risks and benefits of the procedure, and expressing commitment to adhere to long-term dietary and physical activity recommendations post-surgery.
• Willing to maintain consistent dietary iron intake and refrain from taking any iron supplements other than those prescribed by the attending surgeon throughout the study duration.
• Not pregnant during the study period or in the six months prior to enrollment, and not planning to become pregnant for at least 3 months after the final study visit (at 6 months).
• Not breastfeeding in the six weeks prior to enrollment, nor planning to breastfeed during the study.
• No significant weight loss (≥10% of body weight) in the six months prior to the pre-surgical evaluation.
• Signed informed consent.
• No night shift work during the two weeks prior to the baseline visit or at any point during the study (night shift defined as work performed between 12:00 AM and 6:00 AM).
• Not engaging in strenuous physical activity ≥10 hours per week.

You may not qualify if:

• 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).
• Diagnosed abnormalities in iron metabolism based on routine pre-surgical blood samples and unrelated to obesity (e.g., thalassemia).
• History of frequent blood transfusions.
• Chronic liver disease (e.g., alcoholic liver disease, hepatitis C-related liver disease).
• Use of medications that could interfere with study measurements (per investigator's judgment).
• Women consuming ≥14 alcoholic beverages per typical week or men consuming \>21 alcoholic beverages per typical week.

Sponsors & Collaborators

• TecSalud Investigación Clínica: lead
• Fundación Santos y de la Garza Evia, IBP: collaborator

Study Sites (1)

Fundación Santos y de la Garza Evia, IBP

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

The biospecimens collected and retained in this study include: whole blood samples for serum and plasma separation, used for biochemical, hematological, and immunological analyses; subcutaneous and visceral adipose tissue biopsies obtained perioperatively for assessment of cellular iron metabolism and oxidative stress; stool samples for gut microbiota metagenomic sequencing; and urine samples for pregnancy testing prior to DEXA scans. Blood samples will be aliquoted and stored at -80ºC for future analyses. Tissue and stool samples will be processed according to standardized protocols to preserve DNA integrity and cellular components.

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Ana C Cepeda Lopez, PhD

  Fundación Santos y de la Garza Evia, IBP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana C Cepeda Lopez, PhD

CONTACT

210-882-2059; ana.cepeda@tecsalud.mx

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 5, 2025
• Study Start: September 15, 2025
• Primary Completion: November 15, 2025
• Study Completion (Estimated): August 15, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

ME (1)