NCT01489657

Brief Summary

The purpose of this prospective observational study is to generate further insight into the numerous metabolic adaptations associated with sleeve gastrectomy surgery in obese subjects by profiled serum metabolites before and after the surgery and integrated metabolite changes with clinical data.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1.4 years

First QC Date

December 8, 2011

Last Update Submit

June 7, 2016

Conditions

Keywords

ObesityBariatric SurgerySleeve GastrectomyMetabolite Profiling

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The Bariatric Surgery Clinics

You may qualify if:

  • BMI \> 30
  • Willing to undergo sleeve gastrectomy

You may not qualify if:

  • Inability to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson Medical Center, Bariatric Surgery Clinic

Holon, 58100, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zohar Landau, MD

    Wolfson Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pediatric Endocrinology Service

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 9, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

June 1, 2016

Last Updated

June 8, 2016

Record last verified: 2016-06

Locations