Nutritional Status of Patients Before and After Bariatric Surgery

NCT ID: NCT03915158

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-10-31

Brief Summary

This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the sleeve gastrectomy operation.

Detailed Description

Bariatric surgery (BS) is the most effective treatment for severe obesity and comorbidities. Among varieties of BS techniques, sleeve gastrectomy (SG) has gained in popularity worldwide. SG is a procedure involved mainly restriction combined slightly with malabsorption (deficiency in intrinsic factors for vitamin B12 absorption). Considering most patients usually have more than one micronutrients deficiency prior the surgery, the aggravated nutritional status is one of post-surgical concerns. For nutrition management, individualized biochemical assessment for micronutrients is highly recommended in guideline, but is seldom been implanted. Instead, a routine supplementation for vitamins/minerals for postoperative patients is practiced in Taiwan. This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the SG operation. Subjects (n=70-100) will be recruited from patients of Body Science & Metabolic Disorders, International BMI Medical Center of CMUH. The inclusion criteria are Han Chinese, 18-65 years old, and BMI>30 who have arranged for SG operation. Written informed consent will be obtained from participants. Anthropometric data, blood samples, food (including supplements) records and medical history will be collected during the study period. We foresee this study may, not only achieve a personalized dietary plan, but also contribute to indigenous data regarding micronutrient status of obese patients.

Conditions

Nutritional Status

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

bariatric surgery

sleeve gastrectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Han Chinese and Taiwanese
• BMI more than or equal to 27.5
• Surgery type is sleeve gastrectomy

Exclusion Criteria

• Kidney dysfunction
• Mental illness
• Severe eating disorders
• Alcohol or drug abuse
• Stomach ulcers
• Redo bariatric surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Min Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, China Medical University

Locations

China Medical University

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Pei-Min Chao, PhD

Role: CONTACT

pmchao@mail.cmu.edu.tw

+886-4-22053366 ext. 7509

Facility Contacts

Pei-Min Chao, PhD

Role: primary

pmchao@mail.cmu.edu.tw

+886-4-22053366 ext. 7509

References

Lin CH, Liao WL, Wu CC, Shaw HM, Hsu WL, Lu YC, Yang JS, Huang CK, Chao PM. Nutritional Status of Obese Taiwanese Before Bariatric-Metabolic Surgery and Their Serum 25-Hydroxyvitamin D Concentrations for Maximal Suppression of Parathyroid Hormone. Obes Surg. 2020 Oct;30(10):3940-3946. doi: 10.1007/s11695-020-04759-y. Epub 2020 Jul 8.

Reference Type: DERIVED

PMID: 32638247 (View on PubMed)

Other Identifiers

CMUH107-REC1-144

Identifier Type: -

Identifier Source: org_study_id