Plain English Summary
Background and study aims
The serious psychiatric illness anorexia nervosa (AN) is primarily found in teenage girls and young women. The condition is related to several long-term morbidities and mortality but in the majority of cases there is a gradual recovery from the disorder. Intensive nutrition therapy has shown positive results in hospitalized AN patients. The fat mass and obesity-associated (FTO) gene has been associated with increased body weight and body mass index (BMI). The gene seems to be involved in the regulation of hunger and satiety, and is also associated with food intake. The aim of this study is to investigate the potential influence of the FTO gene on BMI and body composition in young women with severe anorexia nervosa during intensive nutrition therapy and after three years.
Who can participate?
Women aged 16-24 with anorexia nervosa
What does the study involve?
All patients are hospitalized for 12 weeks and are treated with an extra-high-energy diet, starting at median 75 kcal/kg/day and step by step declining to 48 kcal/kg/day over the 12-week period. The FTO gene is analyzed at study start and body composition parameters are assessed at the start of the study, after 12 weeks and at 3-year follow-up.
What are the possible benefits and risks of participating?
The treatment given to the participants is the treatment which is routine at the clinic at the time of the study. Participants' body composition is examined at three times, which means a small dose of radiation. Except this, there are no risks of participating. Benefits are that the participants are informed about their bone health and if decreased bone density is diagnosed they are referred to an osteoporotic unit.
Where is the study run from?
Queen Silvia Children’s Hospital (Sweden)
Who is funding the study?
The study is supported by grants from the Queen Silvia Children’s Hospital Research Foundation, ALF grants from Region Östergötland, The Capio Foundation, The Samariten Foundation, The H.K.H Princess Lovisa’s Foundation, The Sahlgrenska University Hospital and The Health & Medical Care Committee of the Regional Executive Board of Region Västra Götaland and by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement (ALFGBG-716831, 678871 and 117661)
Who is the main contact?
Anna Svedlund
anna.svedlund@vgregion.se
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anders Elfvin
ORCID ID
http://orcid.org/0000-0002-1912-9563
Contact details
The Queen Silvia Chidren´s Hospital
Sahlgrenska University Hospital
SU/Östra
Gothenburg
41685
Sweden
+46 (0)722029830
anders.elfvin@vgregion.se
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
DNR 720-11
Study information
Scientific title
The significance of the FTO gene on weight gain and body composition in young Swedish women with severe anorexia nervosa: a three-year follow-up study
Acronym
Anorexia FTO gene study
Study hypothesis
It is hypothesized that polymorphism of the FTO gene could explain the broad spectrum of individual weight gain during nutrition therapy and thereby provide a basis for individualized therapy.
Ethics approval
Approved 20/12/2011, Central Ethical Review Board of Gothenburg (Regionala etikprövningsnämnden i Göteborg, Box 401, 405 30 Gothenburg, Sweden; Tel: +46 (31)7866821; Email: barbro.morsing@epn.gu.se), DNR 720-11
Study design
Single-centre interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Anorexia nervosa
Intervention
Participants were treated for 12 weeks with a high-energy diet. FTO was genotyped and body composition parameters were assessed by dual-energy X-ray absorptiometry and peripheral quantitative computed tomography at baseline, after 12 weeks and at 3-year follow-up.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
BMI and body composition parameters measured with dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) at baseline, after 12 weeks of intensive nutrition therapy and after 3 years
Secondary outcome measures
The frequency and duration of physical activity per week evaluated with the International Physical Activity Questionnaire (IPAQ) at 3 years after nutrition therapy
Overall trial start date
20/12/2011
Overall trial end date
13/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 16 and 24 years
2. Diagnosis of anorexia nervosa according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition
Participant type
Patient
Age group
Mixed
Gender
Female
Target number of participants
25
Participant exclusion criteria
1. Age under 16 years
2. Age above 25 years
3. Individuals with diabetes mellitus or inflammatory bowel disease
Recruitment start date
01/02/2012
Recruitment end date
16/06/2017
Locations
Countries of recruitment
Sweden
Trial participating centre
Queen Silvia Children’s Hospital
Sahlgrenska University Hospital
SU/Ostra sjukhuset
Gothenburg
416 85
Sweden
Sponsor information
Organisation
Sahlgrenska University Hospital
Sponsor details
The Queen Silvia Children's Hospital
SU/Östra
Gothenburg
41685
Sweden
+46 (0)313421000
anders.elfvin@vgregion.se
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
The Sahlgrenska University Hospital and The Health & Medical Care Committee of the Regional Executive Board of Region Västra Götaland and by grants from the Swedish state under the agreement between the Swedish government and the county councils, the ALF-agreement
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Foundation ALF grants from Region Östergötland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Capio Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Samariten Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The H.K.H Princess Lovisa’s Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Queen Silvia Children’s Hospital Research Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results from the study will be published in a peer-reviewed scientific magazine.
IPD sharing statement
This study is based on patient data that cannot be shared publicly because of confidentiality under Swedish law.
Intention to publish date
01/02/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list