Nutritional Status of Patients Before and After Bariatric Surgery

Nutritional Status Clinical Trial

Official title:

Biochemical Evaluations of Nutritional Status of Patients Before and After Bariatric and Metabolic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915158
• Other study ID #: CMUH107-REC1-144
• Status: Recruiting
• Start date: November 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: April 2019
• Source: China Medical University Hospital
• Contact: Pei-Min Chao, PhD
• Phone: +886-4-22053366
• Email: pmchao[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nutritional Status

Intervention

Procedure:
• bariatric surgery
sleeve gastrectomy

Locations

Country	Name	City	State
Taiwan	China Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Nutritional status	Blood sample will be collected and used to determine nutritional status which will measured by laboratory biochemical test.	pre-surgery and 6 months after surgery