Obesity, Morbid Clinical Trial
Official title:
Impact of Bariatric Surgery on Circulating Inflammatory and Pro-vascular Progenitor Cell Populations.
NCT number | NCT04132531 |
Other study ID # | PRO_B_001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | August 13, 2019 |
Verified date | October 2019 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Obesity and diabetes are linked to increased risk for health problems such as heart attack,
stroke, and death. At the cellular level, obesity and diabetes increase levels of harmful
inflammatory cells (M1 macrophages) and decreases levels of protective stem cells
(circulating progenitor cells) in the blood.
Bariatric (weight loss) surgery is an effective treatment that leads to significant weight
loss and improved health in patients with obesity. However, it is unknown if weight loss
surgery also replenishes healthy stem cells and decreases inflammatory cells in the body.
Therefore, the purpose of this research study is to compare levels of these stem and
inflammatory cells before and after bariatric surgery, and to compare to a control group of
healthy normal weight participants.
The investigators anticipate that inflammatory cell levels will be reduced and stem cell
levels and function will be restored after bariatric surgery, similar to levels of healthy
normal weight individuals.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 13, 2019 |
Est. primary completion date | June 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Individuals undergoing bariatric surgery - Must be able to provide two visits, before and after surgery Exclusion Criteria: - Unable to provide written consent - Unable to provide two visits for blood collection |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Humber River Hospital, University of Western Ontario, Canada |
Canada,
Adams TD, Davidson LE, Litwin SE, Kim J, Kolotkin RL, Nanjee MN, Gutierrez JM, Frogley SJ, Ibele AR, Brinton EA, Hopkins PN, McKinlay R, Simper SC, Hunt SC. Weight and Metabolic Outcomes 12 Years after Gastric Bypass. N Engl J Med. 2017 Sep 21;377(12):1143-1155. doi: 10.1056/NEJMoa1700459. — View Citation
Adler BJ, Kaushansky K, Rubin CT. Obesity-driven disruption of haematopoiesis and the bone marrow niche. Nat Rev Endocrinol. 2014 Dec;10(12):737-48. doi: 10.1038/nrendo.2014.169. Epub 2014 Oct 14. Review. — View Citation
Baptista LS, Silva KR, Borojevic R. Obesity and weight loss could alter the properties of adipose stem cells? World J Stem Cells. 2015 Jan 26;7(1):165-73. doi: 10.4252/wjsc.v7.i1.165. Review. — View Citation
Benites BD, Gilli SC, Saad ST. Obesity and inflammation and the effect on the hematopoietic system. Rev Bras Hematol Hemoter. 2014 Mar;36(2):147-51. doi: 10.5581/1516-8484.20140032. Review. — View Citation
Cawley J, Meyerhoefer C. The medical care costs of obesity: an instrumental variables approach. J Health Econ. 2012 Jan;31(1):219-30. doi: 10.1016/j.jhealeco.2011.10.003. Epub 2011 Oct 20. — View Citation
El-Tantawy WH, Haleem EN. Therapeutic effects of stem cell on hyperglycemia, hyperlipidemia, and oxidative stress in alloxan-treated rats. Mol Cell Biochem. 2014 Jun;391(1-2):193-200. doi: 10.1007/s11010-014-2002-x. Epub 2014 Mar 7. — View Citation
Finkelstein EA, Trogdon JG, Cohen JW, Dietz W. Annual medical spending attributable to obesity: payer-and service-specific estimates. Health Aff (Millwood). 2009 Sep-Oct;28(5):w822-31. doi: 10.1377/hlthaff.28.5.w822. Epub 2009 Jul 27. — View Citation
Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458. — View Citation
Forsythe LK, Wallace JM, Livingstone MB. Obesity and inflammation: the effects of weight loss. Nutr Res Rev. 2008 Dec;21(2):117-33. doi: 10.1017/S0954422408138732. Review. — View Citation
Jialal I, Devaraj S, Singh U, Huet BA. Decreased number and impaired functionality of endothelial progenitor cells in subjects with metabolic syndrome: implications for increased cardiovascular risk. Atherosclerosis. 2010 Jul;211(1):297-302. doi: 10.1016/ — View Citation
Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. Review. — View Citation
Kashyap SR, Gatmaitan P, Brethauer S, Schauer P. Bariatric surgery for type 2 diabetes: weighing the impact for obese patients. Cleve Clin J Med. 2010 Jul;77(7):468-76. doi: 10.3949/ccjm.77a.09135. Review. — View Citation
Keidar A. Bariatric surgery for type 2 diabetes reversal: the risks. Diabetes Care. 2011 May;34 Suppl 2:S361-266. doi: 10.2337/dc11-s254. — View Citation
Khan S, Rock K, Baskara A, Qu W, Nazzal M, Ortiz J. Trends in bariatric surgery from 2008 to 2012. Am J Surg. 2016 Jun;211(6):1041-6. doi: 10.1016/j.amjsurg.2015.10.012. Epub 2015 Dec 11. — View Citation
Kizil C, Kyritsis N, Brand M. Effects of inflammation on stem cells: together they strive? EMBO Rep. 2015 Apr;16(4):416-26. doi: 10.15252/embr.201439702. Epub 2015 Mar 4. Review. — View Citation
Mathieu P, Lemieux I, Després JP. Obesity, inflammation, and cardiovascular risk. Clin Pharmacol Ther. 2010 Apr;87(4):407-16. doi: 10.1038/clpt.2009.311. Epub 2010 Mar 3. Review. — View Citation
Mulla CM, Middelbeek RJW, Patti ME. Mechanisms of weight loss and improved metabolism following bariatric surgery. Ann N Y Acad Sci. 2018 Jan;1411(1):53-64. doi: 10.1111/nyas.13409. Epub 2017 Sep 3. Review. — View Citation
Oh J, Lee YD, Wagers AJ. Stem cell aging: mechanisms, regulators and therapeutic opportunities. Nat Med. 2014 Aug;20(8):870-80. doi: 10.1038/nm.3651. Review. — View Citation
Ponce J, DeMaria EJ, Nguyen NT, Hutter M, Sudan R, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of bariatric surgery procedures in 2015 and surgeon workforce in the United States. Surg Obes Relat Dis. 2016 Nov;12(9):1637-1639. doi: 10.1016/j.soard.2016.08.488. Epub 2016 Aug 26. Review. — View Citation
Ponce J, Nguyen NT, Hutter M, Sudan R, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of bariatric surgery procedures in the United States, 2011-2014. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1199-200. doi: 10.1016/j.soard.2015.08.496. Epub 2015 Aug 12. Review. — View Citation
Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. — View Citation
Romeo S, Maglio C, Burza MA, Pirazzi C, Sjöholm K, Jacobson P, Svensson PA, Peltonen M, Sjöström L, Carlsson LM. Cardiovascular events after bariatric surgery in obese subjects with type 2 diabetes. Diabetes Care. 2012 Dec;35(12):2613-7. doi: 10.2337/dc12-0193. Epub 2012 Aug 1. — View Citation
Schauer PR, Bhatt DL, Kirwan JP, Wolski K, Aminian A, Brethauer SA, Navaneethan SD, Singh RP, Pothier CE, Nissen SE, Kashyap SR; STAMPEDE Investigators. Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes. N Engl J Med. 2017 Feb 16;376(7):641-651. doi: 10.1056/NEJMoa1600869. — View Citation
Schauer PR, Burguera B, Ikramuddin S, Cottam D, Gourash W, Hamad G, Eid GM, Mattar S, Ramanathan R, Barinas-Mitchel E, Rao RH, Kuller L, Kelley D. Effect of laparoscopic Roux-en Y gastric bypass on type 2 diabetes mellitus. Ann Surg. 2003 Oct;238(4):467-84; discussion 84-5. — View Citation
Seneviratne AK, Bell GI, Sherman SE, Cooper TT, Putman DM, Hess DA. Expanded Hematopoietic Progenitor Cells Reselected for High Aldehyde Dehydrogenase Activity Demonstrate Islet Regenerative Functions. Stem Cells. 2016 Apr;34(4):873-87. doi: 10.1002/stem. — View Citation
Sherman SE, Kuljanin M, Cooper TT, Putman DM, Lajoie GA, Hess DA. High Aldehyde Dehydrogenase Activity Identifies a Subset of Human Mesenchymal Stromal Cells with Vascular Regenerative Potential. Stem Cells. 2017 Jun;35(6):1542-1553. doi: 10.1002/stem.261 — View Citation
Sjöström L, Peltonen M, Jacobson P, Sjöström CD, Karason K, Wedel H, Ahlin S, Anveden Å, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lönroth H, Narbro K, Näslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914. — View Citation
Stirban AO, Tschoepe D. Cardiovascular complications in diabetes: targets and interventions. Diabetes Care. 2008 Feb;31 Suppl 2:S215-21. doi: 10.2337/dc08-s257. Review. — View Citation
Wu CL, Diekman BO, Jain D, Guilak F. Diet-induced obesity alters the differentiation potential of stem cells isolated from bone marrow, adipose tissue and infrapatellar fat pad: the effects of free fatty acids. Int J Obes (Lond). 2013 Aug;37(8):1079-87. doi: 10.1038/ijo.2012.171. Epub 2012 Nov 20. — View Citation
* Note: There are 29 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in the concentration of oxidative stress and inflammatory markers | Baseline and after surgery, 3-4 months | ||
Primary | Change in the frequency of circulating cells with aldehyde dehydrogenase activity. | Baseline and after surgery, 3-4 months | ||
Secondary | Change in the frequency of circulating cells with aldehyde dehydrogenase activity and cell surface marker expression. | Baseline and after surgery, 3-4 months |
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