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OpenTrials
Completed

NCT Number: NCT03851874

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

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.

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Key information

Conditions

Morbid Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

Bariatric surgery

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 22, 2019
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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