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| Name | Class |
|---|---|
| Germed Pharma | INDUSTRY |
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Obesity is a chronic condition with fat-rich diets playing a major role in its etiology. Pharmacological therapy has been proposed for weight loss and maintenance. This study aims to study the intestinal lipase blockade by partial inhibition of fat absorption after treatment with two commercials formulations of Orlistat.
The overweight and obesity epidemic affects approximately 1.6 millions of people worldwide. Obesity is a chronic condition, associated with premature death, co-morbidities, risk factors for main cardiac disease, stigmatization and significant economic costs. The causes of obesity are complex and include the interplay of environmental, social, economic and genetic factors. Besides fat-rich diets also play a significant role in the etiology of obesity. Correct diet orientation associated with physical exercise usually did not lead to expected result in weight loss and maintenance. Pharmacological therapy has been proposed as an adjunct to achieve the ideal weight. Orlistat acts in reduction of lipids absorption by inhibition of gastric and pancreatic lipases in gastrointestinal tract leading to sustained weight loss. This is a double blind study, randomized, of 2 weeks. The aim of this study was evaluate the intestinal lipase blockade by decrease of fat absorption of fecal fat after treatment with two commercials formulations of Orlistat in obese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orlistat (Lipiblock) treatment | Active Comparator | Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg |
|
| Orlistat (Xenical) treatment | Active Comparator | Xenical is a innovator Orlistat formulation, produced by Roche |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orlistat | Drug | Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition | This study aim to investigate differences in fat absorption inhibition after 7 days treatment with Lipiblock and Xenical (two commercial capsules of Orlistat). Therefore, total fecal fat and fecal fat percentage wil be analysed, comparing these data before and after treatment with Lipiblock and Xeical. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition | This study aim to investigate differences in fat absorption inhibition after 7 days treatment with Lipiblock and Xenical (two commercial capsules of Orlistat). Therefore, total fecal fat and fecal fat percentage wil be analysed, comparing these data before and after treatment with Lipiblock and Xenical. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Geloneze, MD PhD | University of Campinas (UNICAMP) | Principal Investigator |
| Sabrina Nagassaki, PharmD PhD | University of Campinas (UNICAMP) | Study Chair |
| Christiane Stabe, MSc | University of Campinas (UNICAMP) | Study Chair |
| Daniela Tezoto | University of Campinas (UNICAMP) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP) | Campinas | São Paulo | 13083-878 | Brazil |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077403 | Orlistat |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| after 7 days Orlistat treatment |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |