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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
Sponsor:
Information provided by:
Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00592735
First received: January 1, 2008
Last updated: January 11, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Obesity
 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:

U.S. FDA Resources

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

  Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contra-indications to bariatric surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592735

Contacts
Contact: Katherine Samaras, MBBS, FRACP, PhD +61-2-9295-8312 k.samaras@garvan.org.au

Locations
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     k.samaras@garvan.org.au    
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
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Gastroesophageal Reflux
Obesity
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013