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The goal of this randomized clinical trial is to evaluate glycemic control in patients with morbid obesity and type 2 diabetes after Roux-en-Y gastric bypass (RYGBP) and RYGBP with fundus resection. The main questions to answer are:
Patients will randomly undergo typical RYGBP or RYGBP with fundus resection. Gastrointestinal hormones profile [ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), glucagon], glucose levels and insulin response will be measured preoperatively, at 6 months and at 12 months, during 120-min OGTT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RYGBP | Active Comparator | Laparoscopic Roux en Y Gastric Bypass |
|
| RYGBP + FR | Experimental | Laparoscopic Roux en Y Gastric Bypass with fundus resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Roux en Y gastric bypass | Procedure | Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes remission in both groups | Change in HbA1c levels | At 6 months and 12 months postoperatively |
| Change in fasting and postprandial glucose levels | Glucose levels (mg/dl) | At 6 months and 12 months postoperatively |
| Change in insulin levels, fasting and postprandial | Insulin levels (μIU/ml) | At 6 months and 12 months postoperatively |
| Change in HOMA - IR | HOMA IR calculation with glucose (mg/dl) and insulin (mU/L) | At 6 months and 12 months postoperatively |
| Change in ghrelin levels | Fasting and postprandial ghrelin levels (pg/ml) | At 6 months and 12 months postoperatively |
| Change in GLP-1 levels | Fasting and postprandial GLP-1 levels (pg/ml) | At 6 months and 12 months postoperatively |
| Change in PYY levels | Fasting and postprandial PYY levels (ng/ml) | At 6 months and 12 months postoperatively |
| Change in glucagon levels | Fasting and postprandial glucagon levels (pg/ml) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Patras, University Hospital of Patras | Pátrai | Rio | 26504 | Greece |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Laparoscopic Roux en Y gastric bypass with fundus resection | Procedure | Laparoscopic RYGBP included the creation of a small gastric pouch, with a 200cm biliopancreatic limb and a 150cm alimentary limb. Fundus resection is further applied in this arm. |
|
| At 6 months and 12 months postoperatively |
| D004700 | Endocrine System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |