Bariatric Surgery for Morbid Obesity

NCT00675558 | Completed Results

• 2 other identifiers: AAAC0355R01DK072526
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; morbid obesity; bariatric surgery

Outcome Measures

Primary Outcomes (2)

• Size of Adipocytes

  The mean diameters of omental adipocytes were measured

  4 years

• Maximum Reaction Velocity (Vmax) for Facilitated LCFA Uptake

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

  4 years

Secondary Outcomes (1)

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

  4 years

Study Arms (3)

Non-Obese (NO)

Patients with a BMI \< 29.9 scheduled for clinically indicated laparoscopic abdominal surgery.

Procedure: Initial Surgery

Morbidly Obese (MO)

Patients with a BMI \> 40.0 scheduled for clinically indicated laparoscopic abdominal surgery.

Procedure: Initial Surgery

Super-morbidly Obese (SMO)

Patients with a BMI \> 50.0 scheduled for clinically indicated laparoscopic abdominal surgery. 10 subjects of the original 30 subjects enrolled into this group received a second bariatric procedure. The remaining 20 subjects of the original 30 subjects did not continue on to the second phase (second bariatric surgery) of the study.

Procedure: Initial Surgery; Procedure: Second Bariatric Surgery

Interventions

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.

Also known as: 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.

Morbidly Obese (MO); Non-Obese (NO); Super-morbidly Obese (SMO)

Second Bariatric Surgery PROCEDURE

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

Super-morbidly Obese (SMO)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients 18 - 75 years of age
• Scheduled to have two stage bariatric surgery
• BMI \> 50

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and biopsies of omental and subcutaneous fat.

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Paul D. Berk, MD
• Organization: Columbia University Medical Center

pb2158@columbia.edu

2120-305-4491

Study Officials

• Paul D Berk, M.D

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine, Digestive & Liver Diseases

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 9, 2008
• Study Start: November 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: March 1, 2012
• Last Updated: July 26, 2013
• Results First Posted: March 11, 2013

Record last verified: 2013-07

Locations

US (1)