ObesityNCT00675558
Bariatric Surgery for Morbid Obesity
An observational study of Obesity and Morbid Obesity, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Morbid Obesity
- What is being tested?
- Initial Surgery and Second Bariatric Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Mar 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subject population will be drawn from adults referred for bariatric surgery at New York Presbyterian Hospital.
Who may be able to join
- Patients 18 - 75 years of age
- Scheduled to have two stage bariatric surgery
- BMI > 50
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bariatric Surgery for Morbid Obesity: Clinical and Pathophysiologic Consequences
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.
Read the 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 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.
- Conditions
- Obesity, Morbid Obesity
- Being tested
- Initial Surgery, Second Bariatric Surgery
- Keywords
- Obesity, morbid obesity, bariatric surgery
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial SurgeryProcedure or surgery
Also called 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.
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 or surgery
A second bariatric procedure was performed on only 10 of the original 30 Super-morbidly Obese (SMO) subjects.
| Study group | Role | What they receive |
|---|---|---|
| Non-Obese (NO) | Patients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery. Receives: Procedure: Initial Surgery | |
| Morbidly Obese (MO) | Patients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery. Receives: 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. Receives: Procedure: Initial Surgery; Procedure: Second Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of Adipocytes
The mean diameters of omental adipocytes were measured
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.
Measured: 4 years
Secondary outcomes (1)
Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area
Fatty acid uptake was expressed relative to adipocyte cell surface area [Vmax'(pmol/sec/µm^2) = Vmax/(cell surface area) X 10^8].
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startNov 2006
- Primary completionApr 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul D. Berk, Columbia University
- Investigators
- Paul D Berk, M.D, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675558
- Sponsor's protocol ID
- AAAC0355
- Other IDs
- R01DK072526
- Status last verified
- Jul 2013
- First submitted
- 7 May 2008
- Last updated
- 26 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery for Morbid Obesity: Clinical and Pathophysiologic Consequences
- ClinicalTrials.gov ID
- NCT00675558
- Acronym / sponsor ID
- AAAC0355
- Conditions
- Obesity, Morbid Obesity
- Keywords
- Obesity, morbid obesity, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Nov 2006
- Primary completion
- Apr 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Posted 11 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Obese (NO) | – | Procedure: Initial SurgeryPatients with a BMI < 29.9 scheduled for clinically indicated laparoscopic abdominal surgery. |
| Morbidly Obese (MO) | – | Procedure: Initial SurgeryPatients with a BMI > 40.0 scheduled for clinically indicated laparoscopic abdominal surgery. |
| Super-morbidly Obese (SMO) | – | Procedure: Initial Surgery, Procedure: Second Bariatric SurgeryPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will be drawn from adults referred for bariatric surgery at New York Presbyterian Hospital.
Key inclusion criteria (3 listed)
- Patients 18 - 75 years of age
- Scheduled to have two stage bariatric surgery
- BMI > 50
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial SurgeryAlso: 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.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 or surgery | Morbidly Obese (MO), Non-Obese (NO), Super-morbidly Obese (SMO) |
| Second Bariatric SurgeryA second bariatric procedure was performed on only 10 of the original 30 Super-morbidly Obese (SMO) subjects. | Procedure or surgery | Super-morbidly Obese (SMO) |
Primary outcome
Size of Adipocytes
Time frame: 4 years
The mean diameters of omental adipocytes were measured
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.
1 secondary outcome
Maximum Reaction Velocity (Vmax) for Fatty Acid Uptake Relative to Adipocyte Cell Surface Area
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul D Berk, M.D principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Morbid Obesity, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of Adipocytes (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2013.