Bariatric Surgery for Morbid Obesity

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.

Conditions

• Obesity
• Morbid Obesity

Interventions

PROCEDURE

Initial Surgery

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.

PROCEDURE

Second Bariatric Surgery

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Paul D Berk, M.D · Columbia University

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2011-04-30

Completion

2012-03-31

Countries

• United States

Study Locations