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
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