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:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT01347905
Eligibility Criteria:
Inclusion Criteria:
* Women and men
* aged 18 to 50 years
* Premenopausal (had no absence of menstrual cycle in the past 12 months)
* BMI ≥35\<45
* Indication for laparoscopic Sleeve Gastrectomy (LSG) or Laparoscopic Adjustable Gastric Band (LAGB).
Subjects are eligible for this surgery if they:
1. have BMI ≥35\<45 and one of the following two conditions:
* Medical, physical or psychosocial problems associated with their obesity.
* A history of prolonged attempts at weight loss by other means.
2. have been adequately informed and understood and accepted the potential -- risks and benefits of the procedure, and expressed a commitment to follow the rules regarding eating and exercise permanently after the procedure.
* No postoperative complications after the surgery
* Apparently healthy: no significant medical conditions that could influence iron or inflammatory status other than obesity (i.e., cancer, HIV/AIDS, inflammatory bowel disease, gastrointestinal bleeding, and rheumatoid arthritis, renal disease or hemochromatosis) (judged by study physician).
* No use of medication which interferes with study measurements (as judged by the study physician)
* Willing to not change their intake of dietary iron and not take additional iron supplements, other than provided by the study team, between baseline and study end.
* Not being pregnant during the study period or in the six months prior to the study and not planning to become pregnant until at least 3 months after the last study visit.
* Non-lactating in the 6 weeks prior to the study and for the duration of the study
* No reported weight loss ≥ 10 % of bodyweight during a period of six months before pre-surgery examination.
* No full or partial hysterectomy in the past 3 months
* Informed consent signed
* Agreeing to be informed about medically relevant personal test-results by a physician.
* Agreeing to be informed about medically relevant personal test-results by a physician.
* No reported participation in night shift work two weeks prior to pre-study investigation and during the study. Night work is defined as working between midnight and 6.00 AM.
* Consumption of =\< 14 alcoholic drinks in a typical week
* Strenuous exercise =\< 10 hours per week
Exclusion Criteria:
* Reported excessive blood loss at surgery (\> 500 ml) and/or moderate/severe anemic (Hb \< 100 g/L)
* Complications during restrictive bariatric surgery defined as either:
* Surgery duration of \> 3 hours
* Blood loss of \> 500 ml
* Perforation of the gastrointestinal tract
* Inability to adjust lapband
* Women and men with diagnosed abnormalities in iron metabolism (diagnosed from routine pre-surgery blood sample)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01347905
Study Brief:
Protocol Section:
NCT01347905