NCT00592735

Brief Summary

This study will follow ,morbidly obese subjects as they undertake weight loss before and after laparoscopic gastric banding, examining markers of glucose and lipid metabolism, adipokines and measures of body fat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 7, 2016

Status Verified

June 1, 2016

Enrollment Period

5 years

First QC Date

January 1, 2008

Last Update Submit

June 5, 2016

Conditions

Type 2 DiabetesObesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

    6 months

Study Arms (1)

1

Procedure: laparoscopic gastric banding

Interventions

laparoscopic gastric bandingPROCEDURE

standard surgical procedure

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

morbidly obese subjects with type 2 diabetes or metabolic syndrome

You may qualify if:

  • morbidly obese subjects with type 2 diabetes or metabolic syndrome
  • age \<70

You may not qualify if:

  • contra-indications to bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, tissue

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Katherine Samaras

Study Record Dates

First Submitted

January 1, 2008

First Posted

January 14, 2008

Study Start

May 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 7, 2016

Record last verified: 2016-06

Locations

AU(1)