Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices

Morbid Obesity Clinical Trial

Official title:

A Comparative Study of the Effects of Roux en Y Gastric Bypass and Sleeve Gastrectomy on Postprandial Gut Hormone Responses, Glycemia and Lipid Profile, Weight Loss, and Indices of Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03851874
• Other study ID #: Bariatric study
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2019
• Source: National and Kapodistrian University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). Following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI >40 kg/m2

• Age between 18 and 65 years

• Proven failure to lose weight through non-surgical interventions

Exclusion Criteria:

• Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)

• Patients' inability to adhere to postsurgical instructions

• Alcohol or other substance abuse

• Concurrent psychiatric illness

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
Bariatric surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens	Beth Israel Deaconess Medical Center

References & Publications (6)

Dimitriadis GK, Randeva MS, Miras AD. Potential Hormone Mechanisms of Bariatric Surgery. Curr Obes Rep. 2017 Sep;6(3):253-265. doi: 10.1007/s13679-017-0276-5. Review. — View Citation

Farey JE, Preda TC, Fisher OM, Levert-Mignon AJ, Stewart RL, Karsten E, Herbert BR, Swarbrick MM, Lord RV. Effect of Laparoscopic Sleeve Gastrectomy on Fasting Gastrointestinal, Pancreatic, and Adipose-Derived Hormones and on Non-Esterified Fatty Acids. Obes Surg. 2017 Feb;27(2):399-407. doi: 10.1007/s11695-016-2302-1. — View Citation

Holst JJ, Madsbad S. Mechanisms of surgical control of type 2 diabetes: GLP-1 is key factor. Surg Obes Relat Dis. 2016 Jul;12(6):1236-42. doi: 10.1016/j.soard.2016.02.033. Epub 2016 Mar 3. Review. — View Citation

Korner J, Bessler M, Inabnet W, Taveras C, Holst JJ. Exaggerated glucagon-like peptide-1 and blunted glucose-dependent insulinotropic peptide secretion are associated with Roux-en-Y gastric bypass but not adjustable gastric banding. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):597-601. Epub 2007 Oct 23. — View Citation

Laferrère B, Swerdlow N, Bawa B, Arias S, Bose M, Oliván B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25. — View Citation

Yousseif A, Emmanuel J, Karra E, Millet Q, Elkalaawy M, Jenkinson AD, Hashemi M, Adamo M, Finer N, Fiennes AG, Withers DJ, Batterham RL. Differential effects of laparoscopic sleeve gastrectomy and laparoscopic gastric bypass on appetite, circulating acyl-ghrelin, peptide YY3-36 and active GLP-1 levels in non-diabetic humans. Obes Surg. 2014 Feb;24(2):241-52. doi: 10.1007/s11695-013-1066-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in baroreflex sensitivity	Changes in baroreflex sensitivity	3, 6, and 12 months
Other	Change in heart rate variability	Changes in heart rate variability	3, 6, and 12 months
Other	Change in aortic distensibility	Changes in aortic distensibility	3, 6, and 12 months
Other	Change in Tei index	Changes in echocardiographic Tei index	3, 6, and 12 months
Primary	Change in postprandial ghrelin responses	Change in the cumulative postprandial response for ghrelin	3, 6, and 12 months
Primary	Change in postprandial GLP-1 responses	Change in the cumulative postprandial response for GLP-1	3, 6, and 12 months
Primary	Change in postprandial PYY responses	Change in the cumulative postprandial response for PYY	3, 6, and 12 months
Secondary	Change in weight	Change in weight (percentage of weight lost through each procedure)	3, 6, and 12 months
Secondary	Change in postprandial glycemia	Change in the cumulative postprandial response for glucose	3, 6, and 12 months
Secondary	Change in postprandial insulinemia	Change in the cumulative postprandial response for insulin	3, 6, and 12 months
Secondary	Change in postprandial triglyceridemia	Change in the cumulative postprandial response for triglycerides	3, 6, and 12 months