NCT07157332Toborzás még nem indult
Iron Metabolism in Obesity
Dysregulation of Iron Metabolism in Obese Individuals and Its Implications for Metabolic Health
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. szept. 5. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 50 (tervezett)
- Első benyújtás
- 2025. aug. 7.
- Kezdés
- 2025. szept. 15.
- Elsődleges befejezés
- 2025. nov. 15.
- Fő szponzor
- TecSalud Investigación Clínica
- Betegségek
- Elhízás
- NCT-szám
- NCT07157332
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 50
- 2025. szept. 15. és az elsődleges befejezés (2025. nov. 15.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- History of previous surgical obesity treatments.
- Diagnosed abnormalities in iron metabolism based on routine pre-surgical blood samples and unrelated to obesity (e.g., thalassemia).
- Use of medications that could interfere with study measurements (per investigator's judgment).
Más betegség
- 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).
- History of frequent blood transfusions.
- Chronic liver disease (e.g., alcoholic liver disease, hepatitis C-related liver disease).
Laborértékek
- Severe anemia (defined as hemoglobin <100 g/L).
Egyéb
- Participants who have undergone any bariatric procedure other than LAGB or sleeve gastrectomy.
- Women consuming ≥14 alcoholic beverages per typical week or men consuming >21 alcoholic beverages per typical week.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 50 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Fundación Santos y de la Garza Evia, IBP | San Pedro Garza García | Mexikó | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.