Drug Transport in Patients With Anorexia Nervosa

NCT00176150 | Unknown

• 1 other identifier: K075
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa

Keywords

anorexia nervosa; multidrug resistance; cholesterol metabolism

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemiology

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• Walter Emil Haefeli, Prof. Dr.

  Department of Internal Medicine VI, Clinical Pharmacology and Pharmacoepidemilogy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Storch

CONTACT

0049 6221 56 39939; caroline.storch@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Last Updated: September 15, 2005

Record last verified: 2003-04

Locations

DE (1)