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BYM [Bypass and Sleeve gastectomy (Bypass y Manga)]: Mineral absorption and mineral nutritional status in patients with severe and morbid obesity - effects of gastric bypass and sleeve gastrectomy

Studies of the effects of Roux-en-Y gastric bypass and sleeve gastrectomy in morbid obesity on mineral and absorption and metabolism: cellular mechanisms involved

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31937503
Enrollment
40
Registered
2012-08-20
Start date
2008-03-18
Completion date
Unknown
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe and morbid obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

The decision in terms of what type of surgical procedure the patient will undergo (Roux-en-Y gastric bypass or sleeve gastrectomy) is made by the patient's surgeon. After the surgery the individuals
because RYGBP is a restrictive-malabsorptive procedure amounts of micronutrients is greater than that of sleeve gastrectomy. 1. RYGBP group: A vitamin-mineral supplement (Maltofer vi

Sponsors

University of Chile (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Adut pre-menopausal women with body mass index (BMI) > 35 plus some co-morbidities such as hypertension, diabetes, insulin resistance, sleep apnea, dyslipidemia or BMR > 40 regardless the presence of co-morbidities 2. Indication of Roux-en-Y gastric bypass or sleeve gastrectomy 3. The use of a contraceptive method (IUD, oral contraceptives or tubal ligation), will be required prior to participation in the studies due to the use of radioactive isotopes. Furthermore, a pregnancy test will be conducted before the study 4. Consent to participate

Exclusion criteria

Exclusion criteria: 1. Record of inflammatory bowel disease 2. Malabsorption syndrome 3. Liver or pancreatic disease 4. Chronic anemia 5. Low adherence to previous medical treatments 6. Pregnancy

Design outcomes

Primary

MeasureTime frame
1. Zn and Ca determined by the use of stable isotopes 2. Hem Fe and non-hem Fe absorption determined by the use of radioactive isotopes 3. Zn status (Plasma Zn, hair Zn, rapidly exchangeable zinc pool EZP) 4. Ca status (PTH, serum Ca and vitamin D) 5. Fe status (Hemoglobin, hematocrit, zinc-protoporphyrin, serum ferritin, serum transferrin receptor and 6. Cu status (plasma Cu) Measured before and 12 and 24 months after surgery

Secondary

MeasureTime frame
1. Hormone (ghrelin and adiponectine concentrations) measured before and 12 and 24 months after surgery 2. Body composition and bone mineral density (by DEXA) measured before and 12 and 24 months after surgery 3. Mieral-related gene expression (Ca: TRPV5 and TRPV6; Fe: DMT1 and FPN1; Zn: Zip 4 and ZnT1; Cu: hCTR1 and ATP7A) intestinal biopsies before and 12 months after surgery

Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026