Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Medical and Surgical Weight Loss on Metabolism (BOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Garvan Institute of Medical Research.
Recruitment status was  Recruiting
Information provided by:
Garvan Institute of Medical Research Identifier:
First received: January 1, 2008
Last updated: January 11, 2008
Last verified: January 2008

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.

Condition Intervention
Type 2 Diabetes
Procedure: laparoscopic gastric banding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Adipocyte-Derived Inflammatory Cytokines in the Pathogenesis of Diabetes, Dyslipidaemia, Atherosclerosis and Gastro-Oesophageal Reflux Disease: the Effects of Medical and Surgical Weight Loss

Resource links provided by NLM:

Further study details as provided by Garvan Institute of Medical Research:

Primary Outcome Measures:
  • weight loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum, tissue

Estimated Enrollment: 20
Study Start Date: May 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Procedure: laparoscopic gastric banding
standard surgical procedure


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

morbidly obese subjects with type 2 diabetes or metabolic syndrome


Inclusion Criteria:

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

Exclusion Criteria:

  • contra-indications to bariatric surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00592735

Contact: Katherine Samaras, MBBS, FRACP, PhD +61-2-9295-8312

Australia, New South Wales
St Vincent's Hospital Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Katherine Samaras, MBBS FRACP PhD    +61-2-9295-8312   
Principal Investigator: Katherine Samaras, FRACP PhD         
Sub-Investigator: Reginald V Lord, FRACS MD         
Sponsors and Collaborators
Garvan Institute of Medical Research
  More Information

No publications provided

Responsible Party: Katherine Samaras, Garvan Institute of Medical Research Identifier: NCT00592735     History of Changes
Other Study ID Numbers: SVH H06/151, SVH H06/151
Study First Received: January 1, 2008
Last Updated: January 11, 2008
Health Authority: Australia: Human Research Ethics Committee processed this record on March 03, 2015