Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01341028
Status:
COMPLETED
Last Update Posted:
2011-04-25
First Post:
2011-04-18
Brief Title:
Gut Hormones After Roux-en-Y Gastric Bypass RYGBP Plus Gastric Fundus Resection
Sponsor:
University of Patras
Organization:
University of Patras
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-1by the L cells of the distal gut and the suppression of the orexigenic hormone ghrelin released by the stomachObese 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
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-1by the L cells of the distal gut and the suppression of the orexigenic hormone ghrelin released by the stomachObese 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
Detailed Description:
Twenty four patients were included prospectively in the study After randomization 12 patients underwent LRYGBP and 12 LRYGBP plus gastric fundus resection LRYGBPFR
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 LRYGBPFR 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 mealThe 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 postoperative 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 μUml225 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
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 LRYGBPFR 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 mealThe 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 postoperative 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 μUml225 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None