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Trial record 60 of 401 for:    PYY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Bariatric surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gastric bypass bariatric surgery
Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity
Procedure: Bariatric surgery
Bariatric surgery

Active Comparator: Sleeve gastrectomy bariatric surgery
Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity
Procedure: Bariatric surgery
Bariatric surgery




Primary Outcome Measures :
  1. Change in postprandial ghrelin responses [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for ghrelin

  2. Change in postprandial GLP-1 responses [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for GLP-1

  3. Change in postprandial PYY responses [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for PYY


Secondary Outcome Measures :
  1. Change in weight [ Time Frame: 3, 6, and 12 months ]
    Change in weight (percentage of weight lost through each procedure)

  2. Change in postprandial glycemia [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for glucose

  3. Change in postprandial insulinemia [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for insulin

  4. Change in postprandial triglyceridemia [ Time Frame: 3, 6, and 12 months ]
    Change in the cumulative postprandial response for triglycerides


Other Outcome Measures:
  1. Change in baroreflex sensitivity [ Time Frame: 3, 6, and 12 months ]
    Changes in baroreflex sensitivity

  2. Change in heart rate variability [ Time Frame: 3, 6, and 12 months ]
    Changes in heart rate variability

  3. Change in aortic distensibility [ Time Frame: 3, 6, and 12 months ]
    Changes in aortic distensibility

  4. Change in Tei index [ Time Frame: 3, 6, and 12 months ]
    Changes in echocardiographic Tei index



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851874


Sponsors and Collaborators
National and Kapodistrian University of Athens
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Alexandros Kokkinos, MD, PhD First Department of Propaedeutic Medicine, NKUA

Publications:

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Responsible Party: Alexandros Kokkinos, Associate Professor in Internal Medicine, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03851874     History of Changes
Other Study ID Numbers: Bariatric study
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Alexandros Kokkinos, National and Kapodistrian University of Athens:
Bariatric surgery, gut peptides, weight loss, glycemia

Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms