N/A
N=50
Bariatric Surgery for Morbid Obesity
Obesity · Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00675558 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Mar 2013
Primary outcome: Primary: Size of Adipocytes — 73.4; 99.0; 103.0 µm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Initial Surgery (Procedure); Second Bariatric Surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Size of Adipocytes |
73.4; 99.0; 103.0 | — |
| PRIMARY Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake |
8.3; 20.9; 68.7 | — |
| SECONDARY Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area |
0.88; 1.24; 3.21 | — |
Summary
Despite progress in understanding the pathophysiology of obesity, current strategies for its medical management remain largely ineffective. Most efforts have focused on reducing caloric intake or increasing energy expenditure, either through behavior modification (e.g. dieting, regular exercise) alone, or augmented by pharmacologic efforts to decrease appetite, inhibit fat absorption, or alter metabolism. Bariatric surgery remains the only proven long term treatment of morbid obesity.
Super morbidly obese (SMO: Body Mass Index (BMI) > 50) and super super morbidly obese (SSMO: BMI > 60) patients lose considerable weight, but stabilize at Body Mass Indexes (BMIs) that are still obese or even morbidly obese after risking considerable morbidity and/or mortality. Among commonly performed bariatric surgeries, a laparoscopic two-stage procedure, in which an initial restrictive procedure is followed after a weight loss of ~100 lbs by a more complex procedure that creates malabsorption, is gaining interest. Initial studies have demonstrated very good long-term weight loss with minimal morbidity, and no operative mortality in these high risk patients.
Availability of biospecimens obtained at each stage of this protocol will allow participating scientists a unique opportunity to test in human tissues hypotheses developed in animals. Studies proposed under this application focus on fatty acids and overall fat disposition in fat depots (adipose tissue) of your body, and the role of adipose tissue hormones and inflammatory processes in obesity and its associated health related issues.
Eligibility Criteria
Inclusion Criteria
- Patients 18 - 75 years of age
- Scheduled to have two stage bariatric surgery
- BMI > 50
Exclusion Criteria
- Younger than 18 or older than 75 years of age
- Underlying cardiac disease or other medical condition that increases the risk of their surgical procedure
- Pregnancy
- Sufficiently diminished mental capacity so as to be unable to give informed consent.
Data sourced from ClinicalTrials.gov (NCT00675558). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.