Obesity (Disorder)IRON-XLNCT07157332
Iron Metabolism in Obesity
An observational study of Obesity (Disorder), run by TecSalud Investigación Clínica at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Bariatric Sleeve Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 15 Sep 2025to 15 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Fundación Santos y de la Garza Evia, IBP
San Pedro Garza García, Nuevo León, 66278
Linda G Ortega Roldan, BSc, +52 (481) 1006317, lindageraldine99@gmail.com
About this study
Official title: Dysregulation of Iron Metabolism in Obese Individuals and Its Implications for Metabolic Health
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.
Read the detailed description
This is a prospective observational cohort study designed to evaluate changes in clinical, biochemical, and dietary variables related to iron status in adult individuals undergoing restrictive bariatric surgery (laparoscopic sleeve gastrectomy or adjustable gastric banding) in the urban area of Monterrey, Mexico. The main objective is to assess whether iron status prior to surgery influences weight loss success, inflammatory response, and overall health-related quality of life in the six months following surgery.
A total of 50 participants (25 with iron deficiency and 25 without, defined according to WHO standards) will be enrolled. Participants will be classified into groups based on baseline iron status measured using routine preoperative laboratory data. Eligibility criteria include age between 18 and 50 years, premenopausal women, BMI between 35 and 45 kg/m², and eligibility for restrictive bariatric surgery according to international guidelines. Exclusion criteria include prior bariatric surgery, severe anemia (Hb < 100 g/L), medical conditions that may affect inflammation or iron metabolism, chronic liver disease, recent pregnancy or lactation, recent significant weight loss (>10% in the last 6 months), shift work, and high levels of physical activity (>10 hours/week).
All participants will be followed for 6 months after surgery. Outcome assessments include anthropometric measurements, laboratory parameters (hemoglobin, ferritin, CRP, among others), dietary intake, and patient-reported outcomes. Dietary intake will be assessed using MyFitnessPal, a mobile app for dietary tracking, with standardized food entries labeled "IRONXL" based on the Mexican food composition database. Participants will be trained to enter food items accurately and consistently. Data from MyFitnessPal will be exported to obtain nutrient intake data.
Quality of life and general health status will be measured using the PROMIS Global Health questionnaire, a validated 10-item tool. A structured case report form will collect demographic, medical history, and lifestyle data. Blood samples will be collected and stored for potential future research purposes, pending optional consent by participants.
The study will be conducted at the Zambrano Hellion Medical Center, TecSalud. The research team includes qualified surgeons and investigators trained in Good Clinical Practice (GCP). Data quality assurance procedures will include double-entry verification of questionnaire data, standardized anthropometric assessments, and laboratory analyses conducted in accredited clinical laboratories. A Manual of Procedures (MOP) guides all data collection processes.
Missing data will be managed through multiple imputation when appropriate, and all analyses will be conducted according to a pre-specified Statistical Analysis Plan (SAP). The primary outcome is change in weight (kg and % of initial body weight) over 6 months. Secondary outcomes include change in hemoglobin, ferritin, CRP, dietary iron intake, and PROMIS scores.
The sampling method is non-probabilistic and based on convenience sampling of patients scheduled for surgery who meet the eligibility criteria and agree to participate voluntarily. All participants will provide written informed consent before any study procedures.
Optional consent will be obtained for the long-term storage and future analysis of biospecimens (whole blood, serum). These samples may be used in future research related to iron metabolism, inflammation, and nutrition. Participants who decline this optional component will still be eligible to participate in the main study.
- Conditions
- Obesity (Disorder)
- Being tested
- Bariatric Sleeve Surgery
- Keywords
- Obesity, Weight loss, Iron metabolism, Metabolic health, Bariatric surgery, Body composition, Inflammation markers, Dietary assessment
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric Sleeve SurgeryProcedure or surgery
Also called Sleeve Gastrectomy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Bariatric Sleeve Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline (pre-surgery) and 6 months post-surgery.
Secondary outcomes (18)
Percentage of total body fat
Measurement of total body fat percentage using Dual-Energy X-ray Absorptiometry (DEXA) scans.
Measured: Baseline, 3 months, and 6 months after baseline visit.
Lean mass
Measurement of total lean body mass in kilograms using DEXA scans.
Measured: Baseline, 3 months, and 6 months after baseline visit.
Bone mineral density
Measurement of bone mineral density using DEXA scans.
Measured: Baseline, 3 months, and 6 months after baseline visit.
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.
Measured: Baseline and 6 months after baseline visit.
Blood pressure
Measurement of blood pressure using an automated monitor.
Measured: At baseline, 1 month, 3 months, and 6 months post-baseline.
Resting heart rate
Measurement of resting heart rate using an automated monitor.
Measured: Baseline, 1 month, 3 months, and 6 months post-baseline.
Fasting plasma glucose
Measurement of fasting plasma glucose concentration from venous blood samples.
Measured: Baseline, 3 months, and 6 months post-baseline.
Insulin
Measurement of fasting plasma insulin concentration from venous blood samples.
Measured: Baseline, 3 months, and 6 months post-baseline.
Total cholesterol
Measurement of total cholesterol
Measured: Baseline, 3 months, and 6 months post-baseline.
LDL cholesterol
Measurement of LDL cholesterol
Measured: Baseline, 3 months, and 6 months post-baseline.
HDL cholesterol
Measurement of HDL cholesterol
Measured: Baseline, 3 months, and 6 months post-baseline.
Triglycerides
Measurement of triglycerides
Measured: Baseline, 3 months, and 6 months post-baseline.
HOMA-IR index
Calculation of insulin resistance using fasting plasma glucose and insulin values.
Measured: Baseline, 3 months, and 6 months post-baseline.
C-reactive protein
Measurement of serum C-reactive protein concentration using high-sensitivity assay.
Measured: Baseline, 3 months, and 6 months post-baseline.
TNF-α
Measurement of TNF-α
Measured: Baseline, 3 months, and 6 months post-baseline.
IL-6
Measurement of IL-6
Measured: Baseline, 3 months, and 6 months post-baseline.
IL-1β
Measurement of IL-1β
Measured: Measurement of TNF-α, IL-6, and IL-1β
Leptin
Measurement of leptin
Measured: Baseline, 3 months, and 6 months post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TecSalud Investigación Clínica
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Santos y de la Garza Evia, IBP
- Responsible party
- Sponsor
- Investigators
- Ana C Cepeda Lopez, PhD, Principal investigator, Fundación Santos y de la Garza Evia, IBP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157332
- Sponsor's protocol ID
- IPI-D
- Acronym
- IRON-XL
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in publications arising from this study, including data on clinical, anthropometric, and laboratory outcomes, will be shared after de-identification
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulation of Iron Metabolism in Obese Individuals and Its Implications for Metabolic Health
- ClinicalTrials.gov ID
- NCT07157332
- Acronym / sponsor ID
- IRON-XL / IPI-D
- Conditions
- Obesity (Disorder)
- Keywords
- Obesity, Weight loss, Iron metabolism, Metabolic health, Bariatric surgery, Body composition, Inflammation markers, Dietary assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- TecSalud Investigación ClínicaUniversity, hospital or other
- Collaborators
- Fundación Santos y de la Garza Evia, IBP
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective observational cohort study designed to evaluate changes in clinical, biochemical, and dietary variables related to iron status in adult individuals undergoing restrictive bariatric surgery (laparoscopic sleeve gastrectomy or adjustable gastric banding) in the urban area of Monterrey, Mexico. The main objective is to assess whether iron status prior to surgery influences weight loss success, inflammatory response, and overall health-related quality of life in the six months following surgery.
A total of 50 participants (25 with iron deficiency and 25 without, defined according to WHO standards) will be enrolled. Participants will be classified into groups based on baseline iron status measured using routine preoperative laboratory data. Eligibility criteria include age between 18 and 50 years, premenopausal women, BMI between 35 and 45 kg/m², and eligibility for restrictive bariatric surgery according to international guidelines. Exclusion criteria include prior bariatric surgery, severe anemia (Hb < 100 g/L), medical conditions that may affect inflammation or iron metabolism, chronic liver disease, recent pregnancy or lactation, recent significant weight loss (>10% in the last 6 months), shift work, and high levels of physical activity (>10 hours/week).
All participants will be followed for 6 months after surgery. Outcome assessments include anthropometric measurements, laboratory parameters (hemoglobin, ferritin, CRP, among others), dietary intake, and patient-reported outcomes. Dietary intake will be assessed using MyFitnessPal, a mobile app for dietary tracking, with standardized food entries labeled "IRONXL" based on the Mexican food composition database. Participants will be trained to enter food items accurately and consistently. Data from MyFitnessPal will be exported to obtain nutrient intake data.
Quality of life and general health status will be measured using the PROMIS Global Health questionnaire, a validated 10-item tool. A structured case report form will collect demographic, medical history, and lifestyle data. Blood samples will be collected and stored for potential future research purposes, pending optional consent by participants.
The study will be conducted at the Zambrano Hellion Medical Center, TecSalud. The research team includes qualified surgeons and investigators trained in Good Clinical Practice (GCP). Data quality assurance procedures will include double-entry verification of questionnaire data, standardized anthropometric assessments, and laboratory analyses conducted in accredited clinical laboratories. A Manual of Procedures (MOP) guides all data collection processes.
Missing data will be managed through multiple imputation when appropriate, and all analyses will be conducted according to a pre-specified Statistical Analysis Plan (SAP). The primary outcome is change in weight (kg and % of initial body weight) over 6 months. Secondary outcomes include change in hemoglobin, ferritin, CRP, dietary iron intake, and PROMIS scores.
The sampling method is non-probabilistic and based on convenience sampling of patients scheduled for surgery who meet the eligibility criteria and agree to participate voluntarily. All participants will provide written informed consent before any study procedures.
Optional consent will be obtained for the long-term storage and future analysis of biospecimens (whole blood, serum). These samples may be used in future research related to iron metabolism, inflammation, and nutrition. Participants who decline this optional component will still be eligible to participate in the main study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron Deficiency Group | – | Procedure: Bariatric Sleeve SurgeryParticipants 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. |
| Non-Iron Deficiency Group | – | Procedure: Bariatric Sleeve SurgeryParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (13 listed)
- 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:
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric Sleeve SurgeryAlso: Sleeve GastrectomyParticipants 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. | Procedure or surgery | Iron Deficiency Group, Non-Iron Deficiency Group |
Primary outcome
Percentage of Body Weight Loss at 6 Months Post-Surgery
Time frame: Measured at baseline (pre-surgery) and 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.
18 secondary outcomes
Percentage of total body fat
Time frame: Baseline, 3 months, and 6 months after baseline visit.
Lean mass
Time frame: Baseline, 3 months, and 6 months after baseline visit.
Bone mineral density
Time frame: Baseline, 3 months, and 6 months after baseline visit.
Changes in gut microbiota composition
Time frame: Baseline and 6 months after baseline visit.
Blood pressure
Time frame: At baseline, 1 month, 3 months, and 6 months post-baseline.
Resting heart rate
Time frame: Baseline, 1 month, 3 months, and 6 months post-baseline.
Fasting plasma glucose
Time frame: Baseline, 3 months, and 6 months post-baseline.
Insulin
Time frame: Baseline, 3 months, and 6 months post-baseline.
Total cholesterol
Time frame: Baseline, 3 months, and 6 months post-baseline.
LDL cholesterol
Time frame: Baseline, 3 months, and 6 months post-baseline.
HDL cholesterol
Time frame: Baseline, 3 months, and 6 months post-baseline.
Triglycerides
Time frame: Baseline, 3 months, and 6 months post-baseline.
HOMA-IR index
Time frame: Baseline, 3 months, and 6 months post-baseline.
C-reactive protein
Time frame: Baseline, 3 months, and 6 months post-baseline.
TNF-α
Time frame: Baseline, 3 months, and 6 months post-baseline.
IL-6
Time frame: Baseline, 3 months, and 6 months post-baseline.
IL-1β
Time frame: Measurement of TNF-α, IL-6, and IL-1β
Leptin
Time frame: Baseline, 3 months, and 6 months post-baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in publications arising from this study, including data on clinical, anthropometric, and laboratory outcomes, will be shared after de-identification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ana C Cepeda Lopez, PhD principal investigator
Fundación Santos y de la Garza Evia, IBP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity (Disorder), run by TecSalud Investigación Clínica at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana C Cepeda Lopez, PhD (210-882-2059, ana.cepeda@tecsalud.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Body Weight Loss at 6 Months Post-Surgery (time frame: Measured at baseline (pre-surgery) and 6 months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.