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Completed

NCT Number: NCT00675558

Bariatric Surgery for Morbid Obesity

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.

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Key information

Conditions

Obesity Body Weight Morbid Obesity Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University

New York, 10032, United States

About this study

Despite rapidly growing interest in the pathogenesis of the obesity epidemic, the pathophysiology of obesity remain poorly understood. While studies in animals have yielded many insights, it has become clear that human obesity differs in important ways from that in rodents. Bariatric surgery offers better outcomes, but in the highest grades of obesity (BMI>50) remains a high risk undertaking with >5% operative mortality being reported when commonly performed bariatric surgical approaches are employed. By contrast, laparoscopic two-stage approach has resulted in excellent weight loss, minimal morbidity, and <1% mortality.

Availability of blood samples and biopsies of omental and subcutaneous fat from each of the paired bariatric procedures in this protocol will provide a unique opportunity to study key issues in human obesity. This study tests the broad hypothesis that there are significant and as yet unrecognized differences between the pathobiology of obesity in man and rodents, the identification of which may lead to new therapeutic targets. Accordingly, to facilitate comparisons with aspects of obesity we have already investigated in animal models, we will 1. seek fat depot specific differences in Long Chain Fatty Acid (LCFA) disposition, macrophage infiltration and adipokine production in obesity and after surgery-induced weight loss in man, and correlate them with the presence/severity of the metabolic syndrome (MetSyn); and 2., quantify the relative significance and response to weight loss of different mechanisms contributing to hepatic steatosis and the elevated triglycerides (TG) and reduced High-Density Lipoprotein (HDL) typical of obesity and MetSyn.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Initial Surgery

Procedure

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.

Other names: Intervention names:, NO patients all had one surgery: Abdominal Laparoscopic Surgery. Specific procedure determined by underlying medical condition., MO patients all had one surgery: Abdominal Laparoscopic Bariatric Surgery., All 30 SO patients had an initial Abdominal Laparoscopic Bariatric Surgery., The first 10 SMO patients to meet defined requirements had a second Abdominal Laparoscopic Bariatric Surgery. Details below.

Second Bariatric Surgery

Procedure

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

Primary outcomes

  1. Size of Adipocytes

    Time frame: 4 years

    The mean diameters of omental adipocytes were measured

  2. Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake

    Time frame: 4 years

    The Vmax for facilitated Long Chain Fatty Acids (LCFA) uptake by omental adipocytes was measured.

Secondary outcomes

  1. Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area

    Time frame: 4 years

    Fatty acid uptake was expressed relative to adipocyte cell surface area [Vmax'(pmol/sec/µm^2) = Vmax/(cell surface area) X 10^8].

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

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

Registry information

Official study title

Bariatric Surgery for Morbid Obesity: Clinical and Pathophysiologic Consequences

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
May 9, 2008
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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