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Bariatric Surgery for Morbid Obesity
This study is ongoing, but not recruiting participants.
First Received: May 7, 2008   Last Updated: April 16, 2009   History of Changes
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00675558
  Purpose

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: BMI > 50) and super super morbidly obese (SSMO: BMI > 60) patients lose considerable weight, but stabilize at 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 liver, and the role of adipose tissue hormones and inflammatory processes in obesity and its associated health related issues.


Condition
Obesity
Morbid Obesity
Bariatric Surgery

Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Bariatric Surgery for Morbid Obesity: Clinical and Pathophysiologic Consequences

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • To determine the differential, depot specific effects of major weight loss (ca. 100 lb) on cell sizes,rates of LCFA uptake, lipolysis and triglyceride accumulation by adipocytes harvested during bariatric surgery from two distinct human fat depots. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Blood samples and biopsies of liver as well as omental and subcutaneous fat.


Estimated Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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 liver and 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 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 TG and reduced HDL typical of obesity and MetSyn

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The subject population will be drawn from adults referred for bariatric surgery at New York Presbyterian Hospital.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675558

Locations
United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: Paul D Berk, M.D Columbia University
  More Information

No publications provided

Responsible Party: Columbia University ( Paul D. Berk, M.D Professor of Medicine )
Study ID Numbers: DK72526
Study First Received: May 7, 2008
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00675558     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Obesity
morbid obesity
bariatric surgery

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on July 02, 2009