CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Initial Surgery +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00675558
NCT00675558N/ACompleted

Bariatric Surgery for Morbid Obesity: Clinical and Pathophysiologic Consequences

Columbia University·observational·Posted May 9, 2008·Updated Jul 26, 2013

In Brief

An observational study evaluating Initial Surgery and Second Bariatric Surgery for Obesity and Morbid Obesity. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2008
Enrollment StartNov 1, 2006
Primary CompletionApr 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 18.1 years ago

Interventions

Initial Surgeryprocedure

NO patients had initial abdominal laparoscopic surgery at study entry, during which research fat biopsies were obtained, completing their participation. MO patients had initial laparoscopic bariatric surgery (gastric bypass, adjustable gastric band, or sleeve gastrectomy) and fat biopsies at entry, completing their participation. All 30 SMO patients had initial laparoscopic bariatric surgery (sleeve gastrectomy) \& fat biopsies. The first 10 to lose 100 lbs but who needed further surgery to reach optimal weight and who consented to further surgery underwent a 2nd laparoscopic bariatric surgery (either a biliopancreatic diversion with duodenal switch or a Roux-en-Y gastric bypass) and biopsies. The interval between surgeries averaged 15 mos. and the weight loss 55 kg. 30 SMO patients were initially enrolled to insure that 10 would complete 2 surgeries. When 10 had had their 2nd operation, the study was considered complete, and the remaining 20 SMO participants were so notified.

Second Bariatric Surgeryprocedure

A second bariatric procedure was performed on only 10 of the original 30 Super-morbidly Obese (SMO) subjects.