Condition category
Mental and Behavioural Disorders
Date applied
18/12/2019
Date assigned
15/01/2020
Last edited
15/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www2.sahlgrenska.se/en/SU/In-English/

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

Publication citations

Additional files

Editorial Notes

14/01/2020: Trial's existence confirmed by the Regional Research Ethics Committee of Gothenburg, Sweden.