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Study of Fat Malabsorption by Lipiblock Versus Xenical

NCT ID: NCT01170806

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity

Keywords

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Intestinal lipase Orlistat fecal fat obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Orlistat (Lipiblock) treatment

Lipiblock is a new Orlistat formulation, produce by Germed Pharma, Brazil. Capsule 120mg

Group Type ACTIVE_COMPARATOR

Orlistat

Intervention Type DRUG

Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy

Orlistat (Xenical) treatment

Xenical is a innovator Orlistat formulation, produced by Roche

Group Type ACTIVE_COMPARATOR

Orlistat

Intervention Type DRUG

Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy

Interventions

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Orlistat

Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy

Intervention Type DRUG

Other Intervention Names

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Xenical Lipiblock Tetrahydrolipstatin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Germed Pharma

INDUSTRY

Sponsor Role collaborator

University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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University of Campinas, Brazil

Principal Investigators

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Bruno Geloneze, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas (UNICAMP)

Sabrina Nagassaki, PharmD PhD

Role: STUDY_CHAIR

University of Campinas (UNICAMP)

Christiane Stabe, MSc

Role: STUDY_CHAIR

University of Campinas (UNICAMP)

Daniela Tezoto

Role: STUDY_CHAIR

University of Campinas (UNICAMP)

Locations

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LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/University of Campinas (UNICAMP)

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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LIMED0008

Identifier Type: -

Identifier Source: org_study_id