Nutritional Status of Patients Before and After Bariatric... | NCT03915158

Studies
Nutritional Status of Patients Before and After Bariatric Surgery

NCT03915158

Sponsor

China Medical University Hospital

Status

Unknown status

Last Update Posted

Apr 16, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Nutritional Status

Interventions

bariatric surgery

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2018Actual

Primary Completion Date

Oct 31, 2019Estimated

Completion Date

Oct 31, 2019Estimated

First Submitted Date

Mar 27, 2019

First Submission Date that Met QC Criteria

Apr 12, 2019

First Posted Date

Apr 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2019

Last Update Posted Date

Apr 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bariatric surgery	Procedure	sleeve gastrectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects will be recruited from patients of Body Science & Metabolic Disorders International Medical Center.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pei-Min Chao, PhD	Contact	+886-4-22053366	7509	pmchao@mail.cmu.edu.tw

Overall Officials

Name	Affiliation	Role
Pei-Min Chao, PhD	Department of Nutrition, China Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China Medical University	Recruiting	Taichung		40402	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32638247	Derived	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.

ID	Term
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics
D013514	Surgical Procedures, Operative