Anorexia NervosaTEANNCT05575466
Thromboembolism in Anorexia Nervosa
An observational study of Anorexia Nervosa and Thrombosis, run by Odense University Hospital at 5 sites in 2 countries.
Trial summary
BACKGROUND: Sudden death due to thromboembolic (TE) events in patients with anorexia nervosa (AN) is well known. However, the incidence of TE events and the hemostatic balance in patients with AN are sparsely investigated. Also, associations between re-nutrition and the hemostatic balance have not been studied. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Thrombosis, Thromboembolism
- What is being tested?
- Blood samples and Questionnaires
- How many people
- 80 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Nov 2022to 10 Oct 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients with anorexia nervosa and healthy, age-matched controls.
Who may be able to join
- Fulfilling Diagnostic and Statistical Manual V (DSM-5) criteria for AN
- Age 18 - 50 years
- Female sex
- BMI 18.5 - 25.0
- Age 18 - 50 years
- Female sex
Who cannot join
- Somatic comorbidity requiring systemic medications
- Previous thromboembolic event and/or known genetic predisposition
- Use of p.o. hormonal contraception
- Smoking
- Somatic comorbidity requiring systemic medications
- Previous thromboembolic event and/or known genetic predisposition
- Use of p.o. hormonal contraception
- Smoking
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Denmark4 sites
Unit for Thrombosis Research, Department of Clinical Biochemistry, Hospital of South West Jutland
Esbjerg, Jylland, 6700
Clinical Pharmacology and Pharmacy, University of Southern Denmark
Odense, Fyn, 5000
Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark
Odense, Fyn, 5000
The Nutritional Unit, Department of Endocrinology, Center for Eating Disorders, Odense University Hospital and Psychiatry in the region of Southern Denmark
Odense, Fyn, 5220
Sweden1 site
Department of Clinical Sciences, Umeå University
Umeå, Västerbotten County
About this study
Official title: Thromboembolism in Anorexia Nervosa: a Registry-based Study of a National Cohort and a Case-control Study of the Hemostatic Balance and Its Association with Nutritional Status, Insulin and Cortisol
BACKGROUND: Sudden death due to thromboembolic (TE) events in patients with anorexia nervosa (AN) is well known. However, the incidence of TE events and the hemostatic balance in patients with AN are sparsely investigated. Also, associations between re-nutrition and the hemostatic balance have not been studied.
OBJECTIVE: To describe the incidence of TE events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN.
METHODS: The incidence of TE will be described using a Danish cohort of AN patients (n=10,049) with follow-up in national registries. A comprehensive battery of hemostatic biomarkers will be compared in a case-control study of 40 patients with AN and associations between hemostasis and nutritional status will be studied.
Read the detailed description
BACKGROUND
Anorexia nervosa (AN) is a complex psychiatric disorder with concomitant medical complications to malnutrition and starvation and it is associated with the highest mortality of the mental illnesses.
It is estimated that one-third of all deaths in patients with AN are due to cardiac causes, mainly sudden death, and alterations in cardiac electrical activity, structure and hemodynamics have been suggested as mortality causes. Thrombotic disorders such as myocardial infarction, stroke, and pulmonary embolism may also result in sudden cardiac death, and the investigators have previously reported venous thromboembolism in four patients with AN
Whether a disturbed hemostatic balance is associated with re-nutrition, insulin sensitivity and cortisol in AN is unknown. The guidelines of thromboprophylaxis treatment may not be appropriate in this patient group due to metabolic and hemostatic disturbances and increased thrombotic risk of reasons related to refeeding syndrome not listed in current guidelines. To optimize guidelines for AN patients, new evidence is highly warranted
AIMS
This study aims to determine the incidence of venous and arterial thromboembolic events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN. The study will provide new knowledge which qualifies the work of preparing guidelines for thrombosis prophylactic intervention in this patient group.
RESEARCH QUESTIONS
- Is the incidence of venous and arterial thromboembolism increased in patients diagnosed with AN compared to an age-matched control group?
- Is the hemostatic balance disturbed in women with AN compared with healthy, normal-weight women?
- Are cortisol, insulin sensitivity and nutritional status associated with alterations in biomarkers of the hemostatic balance in AN?
The research questions will be answered in three sub studies.
SUB STUDY 1
Sub study 1 will answer research question 1, determining if the incidence of venous and arterial thromboembolism is increased in patients with AN compared to an age-matched control group. The study is based on the comprehensive Danish registries. An already existing cohort of more than 10,000 patients with AN will be evaluated for incidence of thromboembolic events and compared to an age-matched control group.
SUB STUDY 2
Sub study 2 will answer research question 2, exploring the hemostatic balance in patients with AN compared to healthy, normal-weight controls.
Patients with anorexia nervosa (n=40) will be recruited from the highly specialized Center of Eating Disorders at Odense University Hospital. Patients and controls will have blood samples drawn to evaluate the hemostatic balance using a large battery of hemostatic markers.
SUB STUDY 3
Sub study 3 will answer research question 3, clarifying associations between the hemostatic balance and cortisol, insulin sensitivity and nutritional status in AN. Participants of sub study 3 are the patients with AN from sub study 2. From further analysis of the blood samples and by answering validated questionnaires to determine nutritional status and AN severity, research question 3 will be answered.
- Conditions
- Anorexia Nervosa, Thrombosis, Thromboembolism
- Being tested
- Blood samples, Questionnaires
- Keywords
- Anorexia Nervosa, Thrombosis, Thromboembolism, Cortisol, Insulin, Nutrition, Refeeding Syndrome
- Medical subject headings
- Anorexia Nervosa, Thrombosis, Thromboembolism, Insulin Resistance, Refeeding Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesDiagnostic test
Hemostatic biomarkers
QuestionnairesDiagnostic test
Eating Disorder Inventory - third version (EDI-3) Eating Disorder Quality of Life Scale (EDQLS)
| Study group | Role | What they receive |
|---|---|---|
| Patients | Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed Receives: Diagnostic Test: Blood samples; Diagnostic Test: Questionnaires | |
| Controls | Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed Receives: Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thromboembolic events
Arterial and venous thrombosis. Non-fatal outcomes of a thromboembolic event will be validated by the use of anticoagulants in the period immediately after the outcome defining event.
Measured: Data on thromboembolic events are collected from health registries. Data is collected through study completion of the time frame in the registry, up to 26 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start15 Nov 2022
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanie Meincke Egedal, MD, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575466
- Sponsor's protocol ID
- 85860
- Acronym
- TEAN
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboembolism in Anorexia Nervosa: a Registry-based Study of a National Cohort and a Case-control Study of the Hemostatic Balance and Its Association with Nutritional Status, Insulin and Cortisol
- ClinicalTrials.gov ID
- NCT05575466
- Acronym / sponsor ID
- TEAN / 85860
- Conditions
- Anorexia Nervosa, Thrombosis, Thromboembolism
- Keywords
- Anorexia Nervosa, Thrombosis, Thromboembolism, Cortisol, Insulin, Nutrition, Refeeding Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND: Sudden death due to thromboembolic (TE) events in patients with anorexia nervosa (AN) is well known. However, the incidence of TE events and the hemostatic balance in patients with AN are sparsely investigated. Also, associations between re-nutrition and the hemostatic balance have not been studied.
OBJECTIVE: To describe the incidence of TE events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN.
METHODS: The incidence of TE will be described using a Danish cohort of AN patients (n=10,049) with follow-up in national registries. A comprehensive battery of hemostatic biomarkers will be compared in a case-control study of 40 patients with AN and associations between hemostasis and nutritional status will be studied.
Detailed description
BACKGROUND
Anorexia nervosa (AN) is a complex psychiatric disorder with concomitant medical complications to malnutrition and starvation and it is associated with the highest mortality of the mental illnesses.
It is estimated that one-third of all deaths in patients with AN are due to cardiac causes, mainly sudden death, and alterations in cardiac electrical activity, structure and hemodynamics have been suggested as mortality causes. Thrombotic disorders such as myocardial infarction, stroke, and pulmonary embolism may also result in sudden cardiac death, and the investigators have previously reported venous thromboembolism in four patients with AN
Whether a disturbed hemostatic balance is associated with re-nutrition, insulin sensitivity and cortisol in AN is unknown. The guidelines of thromboprophylaxis treatment may not be appropriate in this patient group due to metabolic and hemostatic disturbances and increased thrombotic risk of reasons related to refeeding syndrome not listed in current guidelines. To optimize guidelines for AN patients, new evidence is highly warranted
AIMS
This study aims to determine the incidence of venous and arterial thromboembolic events in patients with AN compared to the background population, to characterize the hemostatic balance in AN compared to normal-weight women, and to assess the associations between the hemostatic balance and nutritional status, insulin sensitivity and cortisol level in women with AN. The study will provide new knowledge which qualifies the work of preparing guidelines for thrombosis prophylactic intervention in this patient group.
RESEARCH QUESTIONS
- Is the incidence of venous and arterial thromboembolism increased in patients diagnosed with AN compared to an age-matched control group?
- Is the hemostatic balance disturbed in women with AN compared with healthy, normal-weight women?
- Are cortisol, insulin sensitivity and nutritional status associated with alterations in biomarkers of the hemostatic balance in AN?
The research questions will be answered in three sub studies.
SUB STUDY 1
Sub study 1 will answer research question 1, determining if the incidence of venous and arterial thromboembolism is increased in patients with AN compared to an age-matched control group. The study is based on the comprehensive Danish registries. An already existing cohort of more than 10,000 patients with AN will be evaluated for incidence of thromboembolic events and compared to an age-matched control group.
SUB STUDY 2
Sub study 2 will answer research question 2, exploring the hemostatic balance in patients with AN compared to healthy, normal-weight controls.
Patients with anorexia nervosa (n=40) will be recruited from the highly specialized Center of Eating Disorders at Odense University Hospital. Patients and controls will have blood samples drawn to evaluate the hemostatic balance using a large battery of hemostatic markers.
SUB STUDY 3
Sub study 3 will answer research question 3, clarifying associations between the hemostatic balance and cortisol, insulin sensitivity and nutritional status in AN. Participants of sub study 3 are the patients with AN from sub study 2. From further analysis of the blood samples and by answering validated questionnaires to determine nutritional status and AN severity, research question 3 will be answered.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Blood samples, Diagnostic Test: QuestionnairesWill have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed |
| Controls | – | Diagnostic Test: Blood samplesWill have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with anorexia nervosa and healthy, age-matched controls.
Key inclusion criteria (6 listed)
- Fulfilling Diagnostic and Statistical Manual V (DSM-5) criteria for AN
- Age 18 - 50 years
- Female sex
- BMI 18.5 - 25.0
- Age 18 - 50 years
Key exclusion criteria (8 listed)
- Somatic comorbidity requiring systemic medications
- Previous thromboembolic event and/or known genetic predisposition
- Use of p.o. hormonal contraception
- Smoking
- Somatic comorbidity requiring systemic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesHemostatic biomarkers | Diagnostic test | Controls, Patients |
| QuestionnairesEating Disorder Inventory - third version (EDI-3) Eating Disorder Quality of Life Scale (EDQLS) | Diagnostic test | Patients |
Primary outcome
Incidence of thromboembolic events
Time frame: Data on thromboembolic events are collected from health registries. Data is collected through study completion of the time frame in the registry, up to 26 years.
Arterial and venous thrombosis. Non-fatal outcomes of a thromboembolic event will be validated by the use of anticoagulants in the period immediately after the outcome defining event.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa and Thrombosis, run by Odense University Hospital at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thromboembolic events (time frame: Data on thromboembolic events are collected from health registries. Data is collected through study completion of the time frame in the registry, up to 26 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.