Clinical trial NCT01170806: Study of Fat Malabsorption by Lipiblock Versus Xenical
Official title: Study of Pharmacodynamic Equivalence of Two Commercial Formulations of Orlistat (Lipiblock vs Xenical) on Intestinal Lipases Inhibition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Intestinal lipase
Orlistat
fecal fat
obesity
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Germed Pharma
First posted: 2010-07-27
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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 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

Primary outcomes:
measure: Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition
timeFrame: baseline
Secondary outcomes:
measure: Study of equivalence between two commercial capsules of Orlistat on fat absorption inhibition
timeFrame: after 7 days Orlistat treatment
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)
state: Sao Paulo
Study officials:
affiliation: University of Campinas (UNICAMP)
name: Bruno Geloneze, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas (UNICAMP)
name: Sabrina Nagassaki, PharmD PhD
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: Christiane Stabe, MSc
role: STUDY_CHAIR
affiliation: University of Campinas (UNICAMP)
name: Daniela Tezoto
role: STUDY_CHAIR
References: