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Trial record 60 of 404 for:    PYY

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

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ClinicalTrials.gov Identifier: NCT03851874
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Alexandros Kokkinos, National and Kapodistrian University of Athens

Tracking Information
First Submitted Date  ICMJE February 21, 2019
First Posted Date  ICMJE February 22, 2019
Last Update Posted Date February 22, 2019
Actual Study Start Date  ICMJE October 2011
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Change in postprandial ghrelin responses [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for ghrelin
  • Change in postprandial GLP-1 responses [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for GLP-1
  • Change in postprandial PYY responses [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for PYY
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
  • Change in weight [ Time Frame: 3, 6, and 12 months ]
    Change in weight (percentage of weight lost through each procedure)
  • Change in postprandial glycemia [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for glucose
  • Change in postprandial insulinemia [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for insulin
  • Change in postprandial triglyceridemia [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for triglycerides
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2019)
  • Change in baroreflex sensitivity [ Time Frame: 3, 6, and 12 months ]
    Changes in baroreflex sensitivity
  • Change in heart rate variability [ Time Frame: 3, 6, and 12 months ]
    Changes in heart rate variability
  • Change in aortic distensibility [ Time Frame: 3, 6, and 12 months ]
    Changes in aortic distensibility
  • Change in Tei index [ Time Frame: 3, 6, and 12 months ]
    Changes in echocardiographic Tei index
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Morbid Obesity
Intervention  ICMJE Procedure: Bariatric surgery
Bariatric surgery
Study Arms  ICMJE
  • Active Comparator: Gastric bypass bariatric surgery
    Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity
    Intervention: Procedure: Bariatric surgery
  • Active Comparator: Sleeve gastrectomy bariatric surgery
    Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity
    Intervention: Procedure: Bariatric surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2019)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03851874
Other Study ID Numbers  ICMJE Bariatric study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alexandros Kokkinos, National and Kapodistrian University of Athens
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Beth Israel Deaconess Medical Center
Investigators  ICMJE
Principal Investigator: Alexandros Kokkinos, MD, PhD First Department of Propaedeutic Medicine, NKUA
PRS Account National and Kapodistrian University of Athens
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP