Prevalence of Major Nutrients Deficiency in Diabetic Pati... | NCT03244839

Studies
Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery

NCT03244839

Sponsor

Min-Sheng General Hospital

Status

Unknown status

Last Update Posted

Aug 10, 2017Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Diabetic Patient Before and After Bariatric Surgery
Nutrition Deficiency(VitB1 VitB12.Ca.Fe)

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jul 28, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 10, 2017Actual

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

Aug 8, 2017

Last Update Posted Date

Aug 10, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

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

No data available

No data is available for this block.

Enrollment

200Estimated

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Cancer on treatment
Uncontrolled psychiatric disease
Drug or alcohol abuser

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Diabetic patients underwent bariatric surgery in MSGH

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Min sheng general hospital		Taoyuan City			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1612328	Result	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.
1858735	Result	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.

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