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Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality from cardiovascular disease.
Metabolic syndrome is strongly associated with obesity, and more specifically with abdominal obesity. Abdominal obesity, comprises two main components: visceral (VAT) and subcutaneous (SAT) adipose tissue depots, with VAT reported as more metabolically active than SAT, and thought to play a major role in the metabolic disturbances associated with obesity and metabolic syndrome.
Non-alcoholic fatty liver disease (NAFLD) is fast becoming the most common liver disease and is associated with obesity, insulin resistance and metabolic syndrome.
Bariatric surgery has yielded dramatic results including longitudinal loss of excess body weight and either complete reversal or significant improvement of several features of metabolic syndrome, NAFLD, and nonalcoholic steatohepatitis (NASH) in obese patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Roux-en-Y Gastric Bypass | Procedure |
Inclusion Criteria:
Exclusion Criteria:
Other exclusions apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Italy, decresg@wyeth.com | Principal Investigator |
| Trial Manager | For Sweden, MedInfoNord@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine | California | 92697-1050 | United States | |||
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| Orange |
| California |
| 92868 |
| United States |
| Atlanta | Georgia | 30322 | United States |
| Indianapolis | Indiana | 46278 | United States |
| Boston | Massachusetts | 02111 | United States |
| Minneapolis | Minnesota | 55455 | United States |
| Cleveland | Ohio | 44195 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Pittsburgh | Pennsylvania | 15240 | United States |
| Dallas | Texas | 75390-9156 | United States |
| Aosta | 11100 | Italy |
| Pisa | 56127 | Italy |
| Roma | 00168 | Italy |
| Gothenburg | 413 45 | Sweden |
| Stockholm | 116 91 | Sweden |
| Stockholm | 141 86 | Sweden |
| Stockholm | 182- 88 | Sweden |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D008659 | Metabolic Diseases |
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| 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 |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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