Nutritional Status of Patients Before and After Bariatric Surgery

• Conditions: Nutritional Status

• Registration Number: NCT03915158
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-03-27
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-12
• Study First Posted: 2019-04-16
• Last Update Posted: 2019-04-16
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of Nutritional status	pre-surgery and 6 months after surgery	Blood sample will be collected and used to determine nutritional status which will measured by laboratory biochemical test.

Trial Locations

Locations (1)

China Medical University; 🇨🇳 Taichung, Taiwan