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Drug Transport in Patients With Anorexia Nervosa

NCT ID: NCT00176150

Last Updated: 2005-09-15

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

UNKNOWN

Study Classification

OBSERVATIONAL

Brief Summary

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The aim of this study is to investigate whether patients with anorexia nervosa have elevated plasma cholesterol levels and, if elevated plasma cholesterol levels influence drug transport by the ABC-transporter P-gp (P-glycoprotein, MDR 1/ABCB1). We will isolate peripheral blood mononuclear cells (PBMCs) and total RNA from the blood of patients with anorexia nervosa and healthy subjects as control. PBMCs will be used for quantitative cholesterol determination and for measuring the activity of P-gp using a FACS (fluorescence-activated cell sorting) method (rhodamine123 efflux). Total RNA will be used for quantitative expression analysis of P-gp by reverse transcriptase real time PCR.

Detailed Description

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Conditions

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Anorexia Nervosa

Keywords

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anorexia nervosa multidrug resistance cholesterol metabolism

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

Diagnosis anorexia nervosa according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders. Washington, DC) Refusal to gain weight to or over a minimal normal weight (BMI \< 17,5 kg/m²) Fear of gaining weight despite underweight


Age matched with patients with anorexia nervosa (18 years to 30 years) Well status of health Female Negative pregnancy test No clinical relevant diagnosis, particularly no hyperlipoproteinemias (LDL \< 160 mg/dl) BMI \> 18,0 kg/m² and \< 25 kg/m²

Exclusion Criteria

Contraindication for taking blood samples (haemoglobin \< 8,5 g/dl) Medication which could influence the lipid metabolism (current and the last two months) Acute or chronic diseases, particularly malign diseases Diseases which could affect the safety of the patients or which could interfere with aims of the study Positive pregnancy test Excessive alcohol consumption (more than 30 g alcohol per day) or alcohol consumption within two days before sampling blood Disability to communicate with the investigator because of linguistic problems or because of a limited mental state


Medication which could influence the lipid metabolism (current and two months ago inclusively) Acute or chronic diseases, particularly malign diseases Diseases which could affect the safety of the patients or which could interfere with aims of the study Positive pregnancy test Excessive alcohol consumption (more than 30 g alcohol per day) or alcohol consumption within two days before sampling blood Disability to communicate with the investigator because of linguistic problems or because of a limited mental state
Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Principal Investigators

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Walter Emil Haefeli, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemilogy

Locations

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Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemiology

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Caroline Storch

Role: CONTACT

Phone: 0049 6221 56 39939

Email: [email protected]

Facility Contacts

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Caroline Storch

Role: primary

Other Identifiers

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K075

Identifier Type: -

Identifier Source: org_study_id