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Drug Transport in Patients With Anorexia Nervosa

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2003 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00176150
First received: September 13, 2005
Last updated: NA
Last verified: April 2003
History: No changes posted
  Purpose

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.


Condition
Anorexia Nervosa

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Influence of Cholesterol Plasma Levels on Drug Transport in Patients With Anorexia Nervosa

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Female
Criteria

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

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

Inclusion criteria for healthy subjects:

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 for healthy subjects:

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176150

Contacts
Contact: Caroline Storch 0049 6221 56 39939 caroline.storch@med.uni-heidelberg.de

Locations
Germany
Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemiology Recruiting
Heidelberg, Germany, 69120
Contact: Caroline Storch     0049 6221 56 39939     caroline.storch@med.uni-heidelberg.de    
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Walter Emil Haefeli, Prof. Dr. Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemilogy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00176150     History of Changes
Other Study ID Numbers: K075
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
anorexia nervosa
multidrug resistance
cholesterol metabolism

Additional relevant MeSH terms:
Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
 Signs and Symptoms
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013