An interventional study of Roux-en-Y gastric bypass (LRYGBP) and LRYGBP+gastric fundus resection in Morbid Obesity, sponsored by University of Patras. Completed at 1 site in Greece. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2011-04-25.
Sponsored by University of Patras · Not applicable, Interventional, and Basic science
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]).
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →University of Patras is the lead sponsor of 69 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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 plus gastric fundus resection
Procedure: LRYGBP+gastric fundus resection
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass
Also known as: LRYGBP
Twelve patients underwent laparoscopic Roux-en-Y gastric bypass and gastric fundus resection
The effects of the resection of the gastric fundus on the secretion of ghrelin, PYY, GLP-1 and insulin.
The effect on the secretion of ghrelin, PYY, GLP-1 and insulin
Time frame: The outcome was assessed 12 months after the operation
The effects of the resection of the gastric fundus on glucose levels, appetite and weight loss
The effect of fundus resection on glucose levels, appetite and weight loss was assessed 12 months after the operation
Time frame: At 12 months after the operation
This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.
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University of Patras