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Nutritional StatusNCT03915158

Nutritional Status of Patients Before and After Bariatric Surgery

An observational study of Nutritional Status, run by China Medical University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Nutritional Status
What is being tested?
bariatric surgery
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteTaiwan
Study dates
1 Nov 2018to 31 Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pei-Min Chao, PhD contact

+886-4-22053366 ext. 7509

pmchao@mail.cmu.edu.tw

Taiwan1 site, 1 recruiting

  • China Medical University

    Taichung, 40402

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

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
bariatric surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bariatric surgeryProcedure or surgery

    sleeve gastrectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Nutritional status

    Blood sample will be collected and used to determine nutritional status which will measured by laboratory biochemical test.

    Measured: pre-surgery and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start1 Nov 2018
  3. Primary completion31 Oct 2019 (estimated)
  4. Study completion31 Oct 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03915158
Sponsor's protocol ID
CMUH107-REC1-144
Status last verified
Apr 2019
First submitted
27 Mar 2019
Last updated
16 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32638247

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional Status, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pei-Min Chao, PhD (+886-4-22053366 ext. 7509, pmchao@mail.cmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Nutritional status (time frame: pre-surgery and 6 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03915158, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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