Study of Fat Malabsorption by Lipiblock Versus Xenical
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Drug: Orlistat |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Study of Pharmacodynamic Equivalence of Two Commercial Formulations of Orlistat (Lipiblock vs Xenical) on Intestinal Lipases Inhibition |
- Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition [ Time Frame: baseline ] [ Designated as safety issue: Yes ]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.
- Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition [ Time Frame: after 7 days Orlistat treatment ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 20 |
| Study Start Date: | October 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Orlistat (Lipiblock) treatment
Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg
|
Drug: Orlistat
Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
Other Names:
|
|
Active Comparator: Orlistat (Xenical) treatment
Xenical is a innovator Orlistat formulation, produced by Roche
|
Drug: Orlistat
Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Obesity
- BMC (Body Mass Index) between 30 to 40 kg/m2
- Women
- 18 to 45 years
- Premenopausal stage
Exclusion Criteria:
- Relevant diseases (diabetes, cardiovascular, gastrointestinal, renal and hepatic diseases, endocrine disorders, hemoglobinopatHy or neoplasm in the last three years)
- Chemical or natural laxatives
- Weight variation greater than 5% in the preceding 3 months
- Surgery for weight reduction
- Drugs to obesity control and/or oral corticosteroids anti-inflammatory in the last three months
Contacts and Locations| Brazil | |
| LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP) | |
| Campinas, Sao Paulo, Brazil, 13083-878 | |
| Principal Investigator: | Bruno Geloneze, MD PhD | University of Campinas (UNICAMP) |
| Study Chair: | 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) |
More Information
No publications provided
| Responsible Party: | Bruno Geloneze, University of Campinas, Brazil |
| ClinicalTrials.gov Identifier: | NCT01170806 History of Changes |
| Other Study ID Numbers: | LIMED0008 |
| Study First Received: | May 18, 2010 |
| Last Updated: | January 28, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Campinas, Brazil:
|
Intestinal lipase Orlistat fecal fat obesity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Orlistat |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Obesity Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012
