Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT07157332
Eligibility Criteria:
Inclusion Criteria:
* 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:
1. 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.
2. 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07157332
Study Brief:
Protocol Section:
NCT07157332