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Nutritional Status of Patients Before and After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT03915158
Recruitment Status : Recruiting
First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Nutritional Status Procedure: bariatric surgery

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biochemical Evaluations of Nutritional Status of Patients Before and After Bariatric and Metabolic Surgery
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: bariatric surgery
    sleeve gastrectomy


Primary Outcome Measures :
  1. Change of Nutritional status [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Whole Blood < 20 mL


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from patients of Body Science & Metabolic Disorders International Medical Center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915158


Contacts
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Contact: Pei-Min Chao, PhD +886-4-22053366 ext 7509 pmchao@mail.cmu.edu.tw

Locations
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Taiwan
China Medical University Recruiting
Taichung, Taiwan, 40402
Contact: Pei-Min Chao, PhD    +886-4-22053366 ext 7509    pmchao@mail.cmu.edu.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Pei-Min Chao, PhD Department of Nutrition, China Medical University

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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03915158     History of Changes
Other Study ID Numbers: CMUH107-REC1-144
First Posted: April 15, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No