Condition category
Mental and Behavioural Disorders
Date applied
12/04/2015
Date assigned
06/05/2015
Last edited
06/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The eating disorder anorexia nervosa (AN) is a serious mental health condition in which people restrict the amount of food they eat to keep their body weight as low as possible. Weight loss in AN can result in an extreme reduction of body fat and lean body mass (LBM), such as muscle. A lot of research has investigated body fat and its distribution in AN patients, but LBM has not really been looked at in depth. Some studies show that AN patients lose more LBM in their arms and legs compared to the trunk of their body. This may be due to other conditions triggered by AN. Unfortunately, the results of these studies are not consistent; some studies found no change in LBM distribution in AN patients. Also, there is very little information on long-term changes in LBM distribution after they have regained a normal body weight. There are also very few studies which have looked at the total body skeletal muscle mass (SM) in patients with AN, and those that have looked at SM have used technology that is not usually available in regular clinics, such as magnetic resonance imaging (MRI) machines. Overall, research investigating LBM, LBM distribution and SM in women with AN before and after regaining a normal body weight are very few, inconsistent and often use methods that are poor or can’t be replicated. The aim of this study is to assess changes in LBM, LBM distribution and SM before and after body weight restoration in a large sample of women with AN.

Who can participate?
Women diagnosed with anorexia nervosa.

What does the study involve?
Patients diagnosed with AN undergo treatment to regain a normal body weight using standard care and inpatient cognitive behavioural therapy (CBT). Following treatment to restore their weight, patients’ post-treatment body composition (LBM, SM) is compared with healthy controls (women who are not AN) of the same age and equivalent body mass index (BMI). All participants have their body composition measured using dual-energy X-ray absorptiometry (DXA).

What are the possible benefits and risks of participating?
There are no risks or benefits to participants

Where is the study run from?
Villa Garda Hospital (Italy)

When is the study starting and how long is it expected to run for?
January 2010 to February 2015

Who is funding the study?
Villa Garda Hospital (Italy)

Who is the main contact?
Dr M El Ghoch (scientific)
marwan1979@hotmail.com

Trial website

www.villagarda.it (Italian)

Contact information

Type

Scientific

Primary contact

Dr Marwan El Ghoch

ORCID ID

http://orcid.org/0000-0003-4277-4752

Contact details

Monte Baldo Street
89
Garda (VR)
37016
Italy
+39 045 8103915
marwan1979@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01_2010

Study information

Scientific title

Changes in lean and skeletal muscle body mass in adult females with anorexia nervosa (AN) before and after weight restoration: a longitudinal study

Acronym

Study hypothesis

During AN, patients lose lean and skeletal muscle body mass especially from extremity regions, and complete weight restoration may overcome this situation.

Ethics approval

Ethics Committee Institutional Review Board of Villa Garda Hospital, Verona, 15/12/2009, ref: 01_2010

Study design

Obeservational longitudinal study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Anorexia nervosa/body composition

Intervention

1. Weight restoration
2. Inpatient cognitive behavioural therapy (CBT)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Changes in lean body mass (LBM) and LBM distribution (extremity and trunk) measured by dual-energy X-ray absorptiometry (DXA) scan before and after weight restoration:
1. Total fat mass (FM): total fat mass in kilograms
2. Total FM percentage (%FM): total FM/total body weight x 100
3. LBM = total lean mass in kilograms
4. LBM percentage (%LBM) = LBM/total body weight x 100
5. Lean trunk mass percentage = lean trunk mass/lean body mass x 100
6. Lean extremity mass percentage = (lean arms mass + lean legs mass)/ lean body mass x 100
7. Lean trunk to extremity ratio = lean trunk mass percentage/lean extremity mass percentage

Secondary outcome measures

Changes in skeletal muscle (SM) with the use of a DXA-validated predictive model (SM = (1.19 x ALM) – 1.01) before and after weight restoration:
1. Appendicular (extremities) lean mass (ALM) in kilograms
2. Total body SM (kg)

Overall trial start date

01/01/2010

Overall trial end date

01/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18–45
2. Diagnosis of AN
3. Body mass index (BMI) ≤18.5 kg/m² at baseline
4. BMI ≥18.5 kg/m² at end of the treatment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

180

Participant exclusion criteria

1. Participants with active substance abuse
2. Participants with schizophrenia or other psychotic disorders

Recruitment start date

10/01/2010

Recruitment end date

01/10/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Villa Garda Hospital
Monte Baldo Street, 89
Garda (VR)
37016
Italy

Sponsor information

Organisation

Villa Garda Hospital

Sponsor details

Monte Baldo Street
89
Garda (VR)
37016
Italy

Sponsor type

Hospital/treatment centre

Website

www.villagarda.it

Funders

Funder type

Hospital/treatment centre

Funder name

Villa Garda Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish several papers in international English peer review journals.

Intention to publish date

01/07/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes