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

Not Applicable

Completed

• Conditions: Severe and morbid obesity; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN31937503
• Lead Sponsor: niversity of Chile (UK)

Brief Summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22952172 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24435517 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29878034 2021 results in https://pubmed.ncbi.nlm.nih.gov/33829230/ (added 09/04/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-20
• Study Completion: 2012-11-30
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 1. Hormone (ghrelin and adiponectine concentrations) measured before and 12 and 24 months after surgery<br> 2. Body composition and bone mineral density (by DEXA) measured before and 12 and 24 months after surgery<br> 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<br>