Morbid ObesityRBNCT00981500
Glucose Homeostasis Pre and Post Bariatric Surgery
An observational study of Morbid Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- gastric bypass, gastric banding and sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 20 (per surgical group) morbidly obese (BMI ≥ 35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.
Who may be able to join
- BMI ≥ 35 kg/m²
- on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies
Who cannot join
- smokes > 7 cigarettes per day
- previous malabsorptive or restrictive intestinal surgery
- pregnant or breastfeeding
- recent history of neoplasia (< 5 years ago)
- have malabsorptive syndromes and inflammatory intestinal disease
- diabetes mellitus
Show all 10Show fewer
- show signs of oral disease or xerostomia (i.e., dry mouth)
- history of chronic rhinitis
- on medication that might affect metabolism
- severe organ dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis
The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.
Read the detailed description
Bariatric surgery is the most effective weight loss therapy for obesity. Moreover, the early improvement in insulin sensitivity and the resolution of type 2 diabetes after bariatric surgery has led to the hypothesis that bariatric surgery has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. Therefore, the primary goal of this proposal is to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action and pancreatic beta cell function.
- Conditions
- Morbid Obesity
- Being tested
- gastric bypass, gastric banding, sleeve gastrectomy
- Keywords
- obesity, gastric bypass, gastric banding, weight loss, insulin sensitivity, sleeve gastrectomy, fibroblast growth factor 21, fibroblast growth factor 19
- Medical subject headings
- Obesity, Morbid, Obesity, Weight Loss, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric bypassProcedure or surgery
Also called Roux-en-Y gastric bypass
Roux-en-Y gastric bypass
gastric bandingProcedure or surgery
Also called lap band
laparoscopic adjustable gastric banding
sleeve gastrectomyProcedure or surgery
Also called gastric sleeve
vertical sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Gastric Bypass | morbidly obese subjects undergoing gastric bypass surgery Receives: Procedure: gastric bypass | |
| gastric banding | morbidly obese subjects undergoing laparoscopic gastric banding surgery Receives: Procedure: gastric banding | |
| sleeve gastrectomy | morbidly obese subjects undergoing sleeve gastrectomy Receives: Procedure: sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action
Measured: at 20% weight loss post surgery
Secondary outcomes (5)
The effect of bariatric surgery-induced weight loss Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on pancreatic beta cell response
Measured: at 20% weight loss post surgery
Determine the effect of bariatric surgery induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on gut microbiota.
Measured: at 20% weight loss post surgery
Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery
Measured: at 20% weight loss post surgery.
Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction
Measured: at 20% weight loss post surgery
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on postprandial plasma fibroblast growth factor (FGF)21 and FGF19 responses.
Measured: at 20% weight loss post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2014
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Sponsor
- Investigators
- Samuel Klein, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981500
- Sponsor's protocol ID
- 09-0175
- Acronym
- RB
- Status last verified
- Aug 2018
- First submitted
- 18 Sep 2009
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.
PubMed 31004409Harris LLS, Smith GI, Mittendorfer B, Eagon JC, Okunade AL, Patterson BW, Klein S. Roux-en-Y Gastric Bypass Surgery Has Unique Effects on Postprandial FGF21 but Not FGF19 Secretion. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3858-3864. doi: 10.1210/jc.2017-01295.
PubMed 28938478Magkos F, Bradley D, Eagon JC, Patterson BW, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on gastrointestinal metabolism of ingested glucose. Am J Clin Nutr. 2016 Jan;103(1):61-5. doi: 10.3945/ajcn.115.116111. Epub 2015 Nov 25.
PubMed 26607940Bradley D, Magkos F, Eagon JC, Varela JE, Gastaldelli A, Okunade AL, Patterson BW, Klein S. Matched weight loss induced by sleeve gastrectomy or gastric bypass similarly improves metabolic function in obese subjects. Obesity (Silver Spring). 2014 Sep;22(9):2026-31. doi: 10.1002/oby.20803. Epub 2014 May 28.
PubMed 24891156Magkos F, Bradley D, Schweitzer GG, Finck BN, Eagon JC, Ilkayeva O, Newgard CB, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on branched-chain amino acid metabolism. Diabetes. 2013 Aug;62(8):2757-61. doi: 10.2337/db13-0185. Epub 2013 Apr 22.
PubMed 23610059Kohli R, Bradley D, Setchell KD, Eagon JC, Abumrad N, Klein S. Weight loss induced by Roux-en-Y gastric bypass but not laparoscopic adjustable gastric banding increases circulating bile acids. J Clin Endocrinol Metab. 2013 Apr;98(4):E708-12. doi: 10.1210/jc.2012-3736. Epub 2013 Mar 1.
PubMed 23457410
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery-induced Weight Loss on Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT00981500
- Acronym / sponsor ID
- RB / 09-0175
- Conditions
- Morbid Obesity
- Keywords
- obesity, gastric bypass, gastric banding, weight loss, insulin sensitivity, sleeve gastrectomy, fibroblast growth factor 21, fibroblast growth factor 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Dec 2009 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.
Detailed description
Bariatric surgery is the most effective weight loss therapy for obesity. Moreover, the early improvement in insulin sensitivity and the resolution of type 2 diabetes after bariatric surgery has led to the hypothesis that bariatric surgery has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. Therefore, the primary goal of this proposal is to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action and pancreatic beta cell function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric Bypass | – | Procedure: gastric bypassmorbidly obese subjects undergoing gastric bypass surgery |
| gastric banding | – | Procedure: gastric bandingmorbidly obese subjects undergoing laparoscopic gastric banding surgery |
| sleeve gastrectomy | – | Procedure: sleeve gastrectomymorbidly obese subjects undergoing sleeve gastrectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 20 (per surgical group) morbidly obese (BMI ≥ 35 kg/m²) subjects scheduled for bariatric surgical procedures will participate in this study.
Key inclusion criteria (2 listed)
- BMI ≥ 35 kg/m²
- on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies
Key exclusion criteria (10 listed)
- smokes > 7 cigarettes per day
- previous malabsorptive or restrictive intestinal surgery
- pregnant or breastfeeding
- recent history of neoplasia (< 5 years ago)
- have malabsorptive syndromes and inflammatory intestinal disease
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 |
|---|---|---|
| gastric bypassAlso: Roux-en-Y gastric bypassRoux-en-Y gastric bypass | Procedure or surgery | Gastric Bypass |
| gastric bandingAlso: lap bandlaparoscopic adjustable gastric banding | Procedure or surgery | gastric banding |
| sleeve gastrectomyAlso: gastric sleevevertical sleeve gastrectomy | Procedure or surgery | sleeve gastrectomy |
Primary outcome
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action
Time frame: at 20% weight loss post surgery
5 secondary outcomes
The effect of bariatric surgery-induced weight loss Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on pancreatic beta cell response
Time frame: at 20% weight loss post surgery
Determine the effect of bariatric surgery induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on gut microbiota.
Time frame: at 20% weight loss post surgery
Identify host genes that co-vary with an altered metagenome in obese individuals that undergo bariatric surgery
Time frame: at 20% weight loss post surgery.
Investigate how the metagenome is affected by bariatric surgery procedures leading to weight reduction
Time frame: at 20% weight loss post surgery
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable gastric banding) on postprandial plasma fibroblast growth factor (FGF)21 and FGF19 responses.
Time frame: at 20% weight loss post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Derived from this study: PubMed 31004409Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.
- Derived from this study: PubMed 28938478Harris LLS, Smith GI, Mittendorfer B, Eagon JC, Okunade AL, Patterson BW, Klein S. Roux-en-Y Gastric Bypass Surgery Has Unique Effects on Postprandial FGF21 but Not FGF19 Secretion. J Clin Endocrinol Metab. 2017 Oct 1;102(10):3858-3864. doi: 10.1210/jc.2017-01295.
- Derived from this study: PubMed 26607940Magkos F, Bradley D, Eagon JC, Patterson BW, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on gastrointestinal metabolism of ingested glucose. Am J Clin Nutr. 2016 Jan;103(1):61-5. doi: 10.3945/ajcn.115.116111. Epub 2015 Nov 25.
- Derived from this study: PubMed 24891156Bradley D, Magkos F, Eagon JC, Varela JE, Gastaldelli A, Okunade AL, Patterson BW, Klein S. Matched weight loss induced by sleeve gastrectomy or gastric bypass similarly improves metabolic function in obese subjects. Obesity (Silver Spring). 2014 Sep;22(9):2026-31. doi: 10.1002/oby.20803. Epub 2014 May 28.
- Derived from this study: PubMed 23610059Magkos F, Bradley D, Schweitzer GG, Finck BN, Eagon JC, Ilkayeva O, Newgard CB, Klein S. Effect of Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding on branched-chain amino acid metabolism. Diabetes. 2013 Aug;62(8):2757-61. doi: 10.2337/db13-0185. Epub 2013 Apr 22.
- Derived from this study: PubMed 23457410Kohli R, Bradley D, Setchell KD, Eagon JC, Abumrad N, Klein S. Weight loss induced by Roux-en-Y gastric bypass but not laparoscopic adjustable gastric banding increases circulating bile acids. J Clin Endocrinol Metab. 2013 Apr;98(4):E708-12. doi: 10.1210/jc.2012-3736. Epub 2013 Mar 1.
- Individual participant dataSharing planned: No
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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.
Samuel Klein, MD principal investigator
Washington University School of Medicine
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 Morbid Obesity, run by Washington University School of Medicine 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 2 inclusion and 10 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 10 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The effect of bariatric surgery-induced weight loss (Roux-en-Y gastric bypass, sleeve gastrectomy, and laparoscopic adjustable banding) on insulin action (time frame: at 20% weight loss post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00981500, which also lists 6 linked publications.
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 10 Aug 2018.