Metabolic Phenotyping in Anorexia Nervosa

Anorexia Nervosa Clinical Trial

Official title:

Metabolic Phenotyping to Predict Risk of Relapse in Patients With Anorexia Nervosa

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02087280
• Other study ID #: VHaas
• Secondary ID: HA 7034/2-1
• Status: Withdrawn
• Phase: N/A
• First received: January 3, 2014
• Last updated: February 10, 2017
• Start date: October 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

After discharge from inpatient treatment, 30-50% of patients with Anorexia Nervosa require re-hospitalization within 4-12 months. So far, high relapse rates are mostly considered as lack of the patient's compliance and motivation to recover. However in studies, psychological relapse predictors explain only a minor part of the variance in relapse risk. Metabolic phenotyping has clinical value to predict weight course in obese patients and we assume that it could also be clinically relevant in patients with AN. We hypothesize that in patients with a dissipative but not with the thrifty phenotype, positive energy balance during refeeding causes an over proportional rise in energy expenditure, counteracts continuous weight gain during inpatient treatment, and increases relapse risk within one year after discharge. Thus we believe that metabolic phenotype as a biological parameter has prognostic value for the disease course in AN.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Anorexia Nervosa

• Between 12 and 18 years of age

• Written and informed consent of patient and parents

• Mental ability to understand the concept of the study

• Inpatient admission to Charité University Clinic with body weight below the 10th BMI-Percentile

Exclusion Criteria:

• Any further disease other than AN with significant influence on body composition and energy metabolism or its assessment

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Locations

Country	Name	City	State
Germany	Charité University Clinic	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Deutsche Forschungegemeinschaft

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse		1 year after discharge
Secondary	Metabolic phenotype		Baseline (during inpatient stay)
Secondary	Biomarkers		Baseline (during inpatient stay)