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Study of Fat Malabsorption by Lipiblock Versus Xenical

Information source: University of Campinas, Brazil
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Orlistat (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Campinas, Brazil

Official(s) and/or principal investigator(s):
Bruno Geloneze, MD PhD, Principal Investigator, Affiliation: University of Campinas (UNICAMP)
Sabrina Nagassaki, PharmD PhD, Study Chair, Affiliation: University of Campinas (UNICAMP)
Christiane Stabe, MSc, Study Chair, Affiliation: University of Campinas (UNICAMP)
Daniela Tezoto, Study Chair, Affiliation: University of Campinas (UNICAMP)

Summary

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.

Clinical Details

Official title: Study of Pharmacodynamic Equivalence of Two Commercial Formulations of Orlistat (Lipiblock vs Xenical) on Intestinal Lipases Inhibition

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition

Secondary outcome: Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition

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

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP), Campinas, Sao Paulo 13083-878, Brazil
Additional Information

Starting date: October 2009
Last updated: January 28, 2011

Page last updated: August 23, 2015

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