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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bariatric surgery
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Bariatric surgery, gut peptides, weight loss, glycemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Gastric bypass bariatric surgery

    Sleeve gastrectomy bariatric surgery

    Arm Description

    Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity

    Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity

    Outcomes

    Primary Outcome Measures

    Change in postprandial ghrelin responses
    Change in the cumulative postprandial response for ghrelin
    Change in postprandial GLP-1 responses
    Change in the cumulative postprandial response for GLP-1
    Change in postprandial PYY responses
    Change in the cumulative postprandial response for PYY

    Secondary Outcome Measures

    Change in weight
    Change in weight (percentage of weight lost through each procedure)
    Change in postprandial glycemia
    Change in the cumulative postprandial response for glucose
    Change in postprandial insulinemia
    Change in the cumulative postprandial response for insulin
    Change in postprandial triglyceridemia
    Change in the cumulative postprandial response for triglycerides

    Full Information

    First Posted
    February 21, 2019
    Last Updated
    February 21, 2019
    Sponsor
    National and Kapodistrian University of Athens
    Collaborators
    Beth Israel Deaconess Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03851874
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (Actual)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National and Kapodistrian University of Athens
    Collaborators
    Beth Israel Deaconess Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity
    Keywords
    Bariatric surgery, gut peptides, weight loss, glycemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Gastric bypass bariatric surgery
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity
    Arm Title
    Sleeve gastrectomy bariatric surgery
    Arm Type
    Active Comparator
    Arm Description
    Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity
    Intervention Type
    Procedure
    Intervention Name(s)
    Bariatric surgery
    Intervention Description
    Bariatric surgery
    Primary Outcome Measure Information:
    Title
    Change in postprandial ghrelin responses
    Description
    Change in the cumulative postprandial response for ghrelin
    Time Frame
    3, 6, and 12 months
    Title
    Change in postprandial GLP-1 responses
    Description
    Change in the cumulative postprandial response for GLP-1
    Time Frame
    3, 6, and 12 months
    Title
    Change in postprandial PYY responses
    Description
    Change in the cumulative postprandial response for PYY
    Time Frame
    3, 6, and 12 months
    Secondary Outcome Measure Information:
    Title
    Change in weight
    Description
    Change in weight (percentage of weight lost through each procedure)
    Time Frame
    3, 6, and 12 months
    Title
    Change in postprandial glycemia
    Description
    Change in the cumulative postprandial response for glucose
    Time Frame
    3, 6, and 12 months
    Title
    Change in postprandial insulinemia
    Description
    Change in the cumulative postprandial response for insulin
    Time Frame
    3, 6, and 12 months
    Title
    Change in postprandial triglyceridemia
    Description
    Change in the cumulative postprandial response for triglycerides
    Time Frame
    3, 6, and 12 months
    Other Pre-specified Outcome Measures:
    Title
    Change in baroreflex sensitivity
    Description
    Changes in baroreflex sensitivity
    Time Frame
    3, 6, and 12 months
    Title
    Change in heart rate variability
    Description
    Changes in heart rate variability
    Time Frame
    3, 6, and 12 months
    Title
    Change in aortic distensibility
    Description
    Changes in aortic distensibility
    Time Frame
    3, 6, and 12 months
    Title
    Change in Tei index
    Description
    Changes in echocardiographic Tei index
    Time Frame
    3, 6, and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandros Kokkinos, MD, PhD
    Organizational Affiliation
    First Department of Propaedeutic Medicine, NKUA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27313194
    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.
    Results Reference
    background
    PubMed Identifier
    17936091
    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.
    Results Reference
    background
    PubMed Identifier
    28780756
    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.
    Results Reference
    background
    PubMed Identifier
    20501690
    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.
    Results Reference
    background
    PubMed Identifier
    23996294
    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.
    Results Reference
    background
    PubMed Identifier
    27465935
    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.
    Results Reference
    background
    PubMed Identifier
    36375643
    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.
    Results Reference
    derived

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

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