Dietary Intake After Laparoscopic Sleeve Gastrectomy -a 5... | NCT02193529

Studies
Dietary Intake After Laparoscopic Sleeve Gastrectomy -a 5 Year Study

NCT02193529

Sponsor

Min-Sheng General Hospital

Status

Unknown status

Last Update Posted

Jul 17, 2014Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Morbid Obesity

Interventions

Not provided

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

ID	Type	Description	Link
DIA5y	Other Identifier	Asia Pacific Bariatric surgery center

Status Module

Record Verification Date

Jul 2014

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

Jun 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jul 8, 2014

First Submission Date that Met QC Criteria

Jul 15, 2014

First Posted Date

Jul 17, 2014Estimated

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

Jul 15, 2014

Last Update Posted Date

Jul 17, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

WEI-CHENG YAO, Institutional Review Board, Min-Sheng General HospitalPrincipal Investigator

Lead Sponsor

Min-Sheng General HospitalOTHER

Collaborators

Not provided

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

Weight reducing surgery is the only effective therapy for morbid obese patients.

Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.

Detailed Description

Weight reducing surgery is the only effective therapy for morbid obese patients. Restrictive type surgery is safer than mal-absorptive type surgery. Laparoscopic sleeve gastrectomy is an effective surgery. In laparoscopic sleeve gastrectomy (LSG), about 90% of the stomach is surgically removed by vertical resection of the great curvature side, including the fundus. The simplicity of surgical procedures, the low occurrence of complications, and the efficiency of reducing excess weight have made LSG as a popular choice for bariatric surgery. After LSG, the amount of food eaten is drastically reduced, leading to nutritional deficiencies potentially. There is poor knowledge about the nutritional status inpatients after LSG. Some literatures suggest that LSG results in less nutritional deficiencies than Roux-en-Y gastric bypass. The aim of our study was to investigate the relationship between dietary intake and weight loss after LSG.

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

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dietary intake after laparoscopic sleeve gastrectomy 5 years	The aim of this study was to investigate the relationship between dietary intake and weight loss effect after sleeve gastrectomy.The calculation of the majority of the nutrients is based on Australian nutrient composition data. The item include: energy ( kcal/day), protein, fat, carbohydrate, vitamin and minerals.	up to 18 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years.

BMI above 40 kg/m2 when operation. Age 18-65 years old. No major psychosis or binge eating disorder. No endocrine disease. failed to lose weight with medical therapy.

Exclusion Criteria:

current hepatitis, under steroid treatment,cancer, thyroid disease,alcoholism.

Accepts Healthy Volunteers

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

morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years. BMI above 40 kg/m2 when operation. Age 18-65 years old.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ju J Chou, university	Contact	886933164297		n002434@e-ms.com.tw
Jung C Chen, university	Contact	886933164297		jackykenzero@gmail.com

Overall Officials

Name	Affiliation	Role
Ju J Chou, university	School of Nutrition and Health Sciences,Taipei Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weight Loss and Metabolic Surgery Center Min-Sheng General Hospital	Recruiting	Taoyuan	Taoyuan	330	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided