Clinical trial NCT03851874: Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Bariatric surgery, gut peptides, weight loss, glycemia
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2019-02-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in postprandial ghrelin responses
timeFrame: 3, 6, and 12 months
measure: Change in postprandial GLP-1 responses
timeFrame: 3, 6, and 12 months
measure: Change in postprandial PYY responses
timeFrame: 3, 6, and 12 months
Secondary outcomes:
measure: Change in weight
timeFrame: 3, 6, and 12 months
measure: Change in postprandial glycemia
timeFrame: 3, 6, and 12 months
measure: Change in postprandial insulinemia
timeFrame: 3, 6, and 12 months
measure: Change in postprandial triglyceridemia
timeFrame: 3, 6, and 12 months
Other outcomes:
measure: Change in baroreflex sensitivity
timeFrame: 3, 6, and 12 months
measure: Change in heart rate variability
timeFrame: 3, 6, and 12 months
measure: Change in aortic distensibility
timeFrame: 3, 6, and 12 months
measure: Change in Tei index
timeFrame: 3, 6, and 12 months
Locations:
Study officials:
affiliation: First Department of Propaedeutic Medicine, NKUA
name: Alexandros Kokkinos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1016/j.soard.2007.08.004. Epub 2007 Oct 23.
citation: 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.
citation: Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan 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.
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.
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.
citation: Angelidi AM, Kokkinos A, Sanoudou D, Connelly MA, Alexandrou A, Mingrone G, Mantzoros CS. Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity. Metabolism. 2023 Jan;138:155346. doi: 10.1016/j.metabol.2022.155346. Epub 2022 Nov 12.