Condition category
Mental and Behavioural Disorders
Date applied
16/05/2014
Date assigned
05/06/2014
Last edited
30/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.villagarda.it/

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

Results - basic reporting

Publication summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25559944

Publication citations

Additional files

Editorial Notes

30/09/2016: Publication reference added.