A study examining the importance of genetic variation for the ability of severely ill anorectic women to gain weight during three years
| ISRCTN | ISRCTN76310580 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76310580 |
| Secondary identifying numbers | DNR 720-11 |
- Submission date
- 18/12/2019
- Registration date
- 15/01/2020
- Last edited
- 15/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
The Queen Silvia Chidren´s Hospital
Sahlgrenska University Hospital
SU/Östra
Gothenburg
41685
Sweden
 ORCID ID |
0000-0002-1912-9563 |
|---|---|
| Phone | +46 (0)722029830 |
| anders.elfvin@vgregion.se |
Study information
| Study design | Single-centre interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | Anorexia FTO gene study |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 20/12/2011 |
| Completion date | 13/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 25 |
| Key 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 |
| Key exclusion criteria | 1. Age under 16 years 2. Age above 25 years 3. Individuals with diabetes mellitus or inflammatory bowel disease |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 16/06/2017 |
Locations
Countries of recruitment
- Sweden
Study participating centre
SU/Ostra sjukhuset
Gothenburg
416 85
Sweden
Sponsor information
Hospital/treatment centre
The Queen Silvia Children's Hospital
SU/Östra
Gothenburg
41685
Sweden
| Phone | +46 (0)313421000 |
|---|---|
| anders.elfvin@vgregion.se | |
| Website | https://www2.sahlgrenska.se/en/SU/In-English/ |
"ROR" |
https://ror.org/04vgqjj36 |
Funders
Funder type
Hospital/treatment centre
No information available
No information available
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results from the study will be published in a peer-reviewed scientific magazine. |
| IPD sharing plan | This study is based on patient data that cannot be shared publicly because of confidentiality under Swedish law. |
Editorial Notes
14/01/2020: Trial's existence confirmed by the Regional Research Ethics Committee of Gothenburg, Sweden.
