NCT03915158

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

12 months

First QC Date

March 27, 2019

Last Update Submit

April 12, 2019

Conditions

Nutritional Status

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

bariatric surgeryPROCEDURE

sleeve gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Han Chinese and Taiwanese
  • BMI more than or equal to 27.5
  • Surgery type is sleeve gastrectomy

You may not qualify if:

  • Kidney dysfunction
  • Mental illness
  • Severe eating disorders
  • Alcohol or drug abuse
  • Stomach ulcers
  • Redo bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 40402, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32638247DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood \< 20 mL

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Pei-Min Chao, PhD

    Department of Nutrition, China Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Min Chao, PhD

CONTACT

+886-4-22053366pmchao@mail.cmu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

April 16, 2019

Study Start

November 1, 2018

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

TW(1)