Clinical trial NCT03915158: Nutritional Status of Patients Before and After Bariatric Surgery
Official title: Biochemical Evaluations of Nutritional Status of Patients Before and After Bariatric and Metabolic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nutritional Status
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from patients of Body Science \& Metabolic Disorders International Medical Center.

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.

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

Primary outcomes:
measure: Change of Nutritional status
timeFrame: pre-surgery and 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: Department of Nutrition, China Medical University
name: Pei-Min Chao, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.