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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26560758 (added 22/01/2019)