NCT03244839

Brief Summary

The increasing demand of bariatric surgery requires ongoing improvement of the preoperative and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery mainly focuses on weight loss, improvement of co-morbidities and quality of life. Post-operative nutritional deficiencies are a complication of bariatric surgery, in particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and D are frequently reported and may occur despite supplementation. Morbid obesity itself is associated with nutritional deficiencies as well, which become worsening after bariatric surgery. The occurrence of nutritional deficiencies has been reported in the literature but not in Taiwan. The goal of the current study is to determine the prevalence and incidence of nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving standard supplementation in Taiwan.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration 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

January 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 10, 2017

Status Verified

July 1, 2017

Enrollment Period

2.9 years

First QC Date

July 28, 2017

Last Update Submit

August 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery

    Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery

    3 years

Interventions

bariatric surgery

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Diabetic patients underwent bariatric surgery in MSGH

You may qualify if:

  • Age: 20\~65
  • Diabetic patients underwent bariatric surgery in MSGH

You may not qualify if:

  • Pregnancy
  • Cancer on treatment
  • Uncontrolled psychiatric disease
  • Drug or alcohol abuser

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Min sheng general hospital

Taoyuan, Taiwan

Location

Related Publications (3)

  • Shiffman ML, Sugerman HJ, Kellum JM, Moore EW. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992 Jul;103(1):214-21. doi: 10.1016/0016-5085(92)91115-k.

  • Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.

  • Williams C, Gowan R, Perey BJ. A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty. Obes Surg. 1993 Aug;3(3):257-259. doi: 10.1381/096089293765559278.

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 10, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 10, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations