Plain English Summary
Background and study aims
Anorexia nervosa is an eating disorder in which people keep their body weight at low as possible by restricting the amount of food they eat, vomiting and excessive exercise. It leads to weight loss and a reduction of body mass. A severe loss in body weight can lead to a number of physical problems, such as extreme tiredness, headaches/abdominal pains, poor circulation and females can stop having their periods. These symptoms can only be treated by an adequate increase in weight and distribution of body mass. Available data suggest that during anorexia nervosa, adolescent females seem to lose more fat around their belly (central body fat), while adult females more peripheral fat (fat found elsewhere on the body). When these patients then regain their weight, adult females tend to deposit their newly acquired fat around their belly (central regions) while adolescents regain similar body fat distributions to non-sufferers with no increase in the proportion of belly fat. However, results reported in adolescent females are not consistent and need further investigation, and no comparison has made between adult and adolescent individuals that have undergone the same treatment. The aim of this study is to assess body fat mass and its distribution before and after regaining weight in adolescent and adult individuals with anorexia nervosa treated with same treatment (duration and weight gain rate).
Who can participate?
Female patients with a diagnosis of anorexia nervosa (adolescents 13-19 years, adults 20 years or over)
What does the study involve?
All patients with anorexia nervosa receive the same inpatient treatment based on gaining weight and enhanced cognitive behavioural therapy (CBT-E). Tests were done to measure body composition in all patients.
What are the possible benefits and risks of participating?
The benefits are the improvement of physical, psychological and social status of patients. There is no risk in participating in the study.
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 2012 to July 2014
Who is the funding the study?
Villa Garda Hospital (Italy)
Who is the main contact?
Dr Marwan El Ghoch
marwan1979@hotmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Marwan El Ghoch
ORCID ID
Contact details
Via Monte Baldo
89
Garda
37016
Italy
+39 (0)45 620 8611
marwan1979@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
02
Study information
Scientific title
Regional fat distribution in adolescent girls and adults with anorexia nervosa: a longitudinal study
Acronym
Study hypothesis
Available data indicate that adults with anorexia nervosa, but not adolescents, seems to have different body fat distribution with respect to healthy controls before and after immediate weight normalization. However, to date no study compared the effect weight restoration on body fat distribution in adults and adolescents with AN under the same circumstance (identical treatment). It is therefore possible that the differences observed in adults and adolescents with anorexia nervosa might be the results of different modality of nutritional rehabilitation and rate of weight regain. On the basis of this premise, we aimed to study adults and adolescents with anorexia nervosa with the same treatment to investigate if really exists a difference in body fat distribution after immediate weight restoration between the two populations.
Ethics approval
Institutional Review Board of Villa Garda Hospital, 15/12/2011, ref. 02_2012
Study design
Longitudinal study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Anorexia nervosa/body composition
Intervention
We recruited 66 female patients with a diagnosis of anorexia nervosa and 66 controls of the same age (+ 2 years) with a BMI equivalent to the patients BMI after weight restoration for an observational study. The interventions are weight restoration and inpatient cognitive behavioural therapy. All patients received the same treatment. Body composition was measured using dual-energy X-ray absorptiometry (DXA) in anorexia nervosa patients and in healthy controls.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Change in fat masses and their distribution (using DXA) before and after complete weight restoration in AN patients
Secondary outcome measures
Body composition and fat distribution (using DXA) of weight-restored AN patients
Overall trial start date
01/01/2012
Overall trial end date
01/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients aged 13 - 50 years (adolescents 13-19 years; adults ≥ 20 years)
2. Diagnosis of anorexia nervosa
3. BMI ≤18.5 kg/m² in adults or BMI percentiles ≤18.5 kg/m² in adolescents at time zero
4. BMI ≥ 18.5 kg/m² in adults or BMI percentiles correspondent to a BMI ≥ 18.5 kg/m² at the end of the treatment
Participant type
Patient
Age group
Other
Gender
Female
Target number of participants
66 female patients with a diagnosis of anorexia nervosa, and 66 controls of the same age (+ 2 years) with a BMI equivalent to the patients BMI after weight restoration.
Participant exclusion criteria
1. Participants that do not satisfy inclusion criteria
2. Participants with active substance abuse, schizophrenia and other psychotic disorders
Recruitment start date
01/01/2012
Recruitment end date
01/07/2014
Locations
Countries of recruitment
Italy
Trial participating centre
Villa Garda Hospital
Garda
37016
Italy
Sponsor information
Organisation
Villa Garda Hospital (Italy)
Sponsor details
Via Monte Baldo
89
Garda
37016
Italy
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Villa Garda Hospital (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25559944