Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the impact of weight loss due to bariatric surgery, as compared to the effect of optimal medical therapy alone on endothelial function, subclinical atherosclerosis, cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study consists in a 2-arm randomized trial, in which patients will be randomly assigned to bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0) and 12 months thereafter (T1).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric Surgery | Experimental | Gastric bypass |
|
| Optimal Medical Therapy | Active Comparator | planned visits, optimized hypoglycemic treatment, diet and lifestyle modification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass | Procedure | A subcardial gastric pouch with a 30±10 ml capacity will be created by sectioning the stomach with a linear stapler 3-4 cm horizontally on the lesser curve, 4 cm distal to the e-g junction, and then vertically until attainment of the angle of Hiss. After identification of the Treitz ligament, the jejunum will be transected at 100 cm from the ligament of Treitz and the two stumps will be closed. The distal stump will be anastomosed to the distal end of the gastric pouch. The preferred gastro-jejunal anastomosis is the totally hand-sewn one, but it can be performed using any other the technique the surgeon is more familiar with. Finally, the proximal stump of the transacted bowel will be joined end-to-side to the jejunum 150 cm distal to the gastro-enterostomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness) | ecographic assessment of carotid artery intima-media thickness | 12 months |
| Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation) | ecographic assessment of flow-mediated dilation and nitrate mediated dilation | 12 months |
| Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings) | heart rate variability measurements on 24-hour Holter ECG recordings | 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Medical therapy | Behavioral |
|
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
Not provided
Not provided