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Trial record 11 of 406 for:    PYY

Gut Hormones After Roux-en-Y Gastric Bypass (RYGBP) Plus Gastric Fundus Resection

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ClinicalTrials.gov Identifier: NCT01341028
Recruitment Status : Completed
First Posted : April 25, 2011
Last Update Posted : April 25, 2011
Sponsor:
Information provided by:
University of Patras

Brief Summary:
  • Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of restriction-malabsorption procedure and one of the most common operative procedures implemented.
  • Over the last years increasing evidence suggests that the beneficial effects of bariatric operations might be related to the suppression of appetite caused by the release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food intake.
  • In the present study the investigators sought to evaluate the effects of the resection of the gastric fundus, the main source of ghrelin production, on the secretion of ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Roux-en-Y gastric bypass (LRYGBP) Procedure: LRYGBP+gastric fundus resection Not Applicable

Detailed Description:

Twenty four patients were included prospectively in the study. After randomization, 12 patients underwent LRYGBP and 12 LRYGBP plus gastric fundus resection (LRYGBP+FR).

All human studies were performed according to the principles of the Declaration of Helsinki. The local Research and Ethics Commitee at the University Hospital of Patras approved the study. Written informed consent was obtained from all patients.

All the operations were performed by the same surgeon laparoscopically. The RYGBP procedures were performed creating a small isolated lesser curve-based gastric pouch (20 ± 5 ml) and a 150cm Roux limb. The gastroenteroanastomosis was conducted with a 25 mm circular stapler. The dissection of the fundus of the stomach in the (LRYGBP+FR) group was done with the use of EndoGia No 60.

The subjects were studied before and at 3, 6 and 12 months after the operation. All the patients underwent an oral glucose tolerance test (OGTT) with 75 g glucose, preoperatively. In addition, venous blood was collected after an overnight 12 hour fast and 30, 60 and 120 min after the administration of a 300 kcal mixed meal.The meal was consumed in ten minutes and consisted of 18% protein, 55% carbohydrate and 27% fat (Resource energy drink, Nestle Nutrition, France). Plasma levels of PYY, GLP-1, ghrelin and insulin were determined at every time point of the study. All patients underwent complete clinical evaluation during follow-up including nutritional, behavioral and anthropometric parameters. Visual analogue scales (VAS) were used to measure hunger, nausea, fullness and aversion to food, before and 30, 60 and 120 min after the consumption of the meal. Weight loss evaluation was based on postope¬rative body weight, body mass index (BMI) and % excess weight loss (EWL %).

Insulin resistance was approximated using the homeostatic model assessment for insulin resistance (HOMA IR). The following formula was used in its calculation:

HOMA IR = (fasting glucose [mmole] /lt X fasting insulin [μU/ml])/22.5). The insulinogenic index, a commonly used indicator of pancreatic β-cell function, was calculated as the ratio of increment of insulin concentrations to that of glucose concentrations at 30 minutes after meal ingestion (Δ [ins30 - ins0] / Δ [Glu30 -Glu0]).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of the Resection of the Gastric Fundus on the Secretion of Ghrelin, Peptide-YY, Glucagon-like Peptide-1 and Insulin Secretion in Morbidly Obese Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass
Study Start Date : May 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Active Comparator: Roux-en-Y gastric bypass (LRYGBP)
Twelve subjects underwent laparoscopic Roux-en-Y gastric bypass
Procedure: Roux-en-Y gastric bypass (LRYGBP)
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass
Other Name: LRYGBP

Experimental: LRYGBP plus gastric fundus resection
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass plus gastric fundus resection
Procedure: LRYGBP+gastric fundus resection
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass and gastric fundus resection




Primary Outcome Measures :
  1. The effects of the resection of the gastric fundus on the secretion of ghrelin, PYY, GLP-1 and insulin. [ Time Frame: The outcome was assessed 12 months after the operation ]
    The effect on the secretion of ghrelin, PYY, GLP-1 and insulin


Secondary Outcome Measures :
  1. The effects of the resection of the gastric fundus on glucose levels, appetite and weight loss [ Time Frame: At 12 months after the operation ]
    The effect of fundus resection on glucose levels, appetite and weight loss was assessed 12 months after the operation



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index higher than 40 kg/m2

Exclusion Criteria:

  • pregnancy
  • diabetes mellitus
  • substance abuse
  • chronic medical or psychiatric illness
  • previous gastrointestinal surgery

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): NCT01341028


Locations
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Greece
University Hospital of Patras
Rion, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras
Investigators
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Principal Investigator: Theodore K Alexandrides Professor of Medicine, School of Medicine, University of Patras

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Responsible Party: Theodore K. Alexandrides, Professor of Medicine, University of Patras School of Medicine
ClinicalTrials.gov Identifier: NCT01341028     History of Changes
Other Study ID Numbers: RYGBPFR001
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: April 25, 2011
Last Verified: February 2007
Keywords provided by University of Patras:
weight loss
appetite
ghrelin
PYY
GLP-1
insulin
laparoscopic
Roux-en-Y gastric bypass
gastric fundus resection
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs