Can Genetic Markers Predict Weight Loss After Gastric By-... | NCT01736384

Studies
Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery

NCT01736384

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Feb 28, 2020Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Obesity

Interventions

Gastric bypass or cholecystectomy

Countries

Sweden

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009Actual

Primary Completion Date

Feb 2020Actual

Completion Date

Feb 2020Actual

First Submitted Date

Nov 12, 2012

First Submission Date that Met QC Criteria

Nov 26, 2012

First Posted Date

Nov 29, 2012Estimated

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

Feb 27, 2020

Last Update Posted Date

Feb 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erik Näslund, Professor, Karolinska InstitutetPrincipal Investigator

Lead Sponsor

Karolinska InstitutetOTHER

Collaborators

Name	Class
Danderyd Hospital	OTHER
Ersta Hospital, Sweden	OTHER
Karolinska University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obesity		Gastric bypass surgery and non-obese controls undergoing cholecystectomy	Procedure: Gastric bypass or cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric bypass or cholecystectomy	Procedure		Obesity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Genetic markers	Blood samples and tissue biopsies taken at the time of surgery and at follow-up.	day of surgery and 1 and 2 years after surgery

Secondary Outcomes

Measure	Description	Time Frame
Lipid and protein patterns in plasma and tissues	Blood samples taken and tissue biopsies taken at the time of surgery and at follow-up	day of surgery and at 1 and 2 years postoperatively
Previous viral infection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

laparoscopic gastric by-pass with BMI greater than 35

Exclusion Criteria:

unable to understand swedish

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

Obesity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erik Näslund, Professor	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institutet, Ersta Hospital		Stockholm		SE-116 91	Sweden
Karolinska Institutet, Danderyds Hospital

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015390	Gastric Bypass
D002763	Cholecystectomy

Ancestor Terms

ID	Term
D050110	Bariatric Surgery
D049088	Bariatrics
D000073319	Obesity Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided