Thromboembolism in Anorexia Nervosa

NCT05575466 | Completed DMC

• 1 other identifier: 85860
• Study Type: observational
• Target: 80
• Locations: 2 countries
• Sites: 5

Brief 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. 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.

Conditions

Anorexia Nervosa; Thrombosis; Thromboembolism

Keywords

Anorexia Nervosa; Thrombosis; Thromboembolism; Cortisol; Insulin; Nutrition; Refeeding Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Other Outcomes (2)

• Hemostatic balance

  The study is cross-sectional. Time frame for completion of participation in the study is 1 day.

• Rotational Thromboelastometry (ROTEM)-variables

  The study is cross-sectional. Time frame for completion of participation in the study is 1 day.

Study Arms (2)

Patients

Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed

Diagnostic Test: Blood samples; Diagnostic Test: Questionnaires

Controls

Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed

Diagnostic Test: Blood samples

Interventions

Blood samples DIAGNOSTIC_TEST

Hemostatic biomarkers

Controls; Patients

Questionnaires DIAGNOSTIC_TEST

Eating Disorder Inventory - third version (EDI-3) Eating Disorder Quality of Life Scale (EDQLS)

Patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with anorexia nervosa and healthy, age-matched controls.

You may qualify if:

• Fulfilling Diagnostic and Statistical Manual V (DSM-5) criteria for AN
• Age 18 - 50 years
• Female sex

You may not qualify if:

• Somatic comorbidity requiring systemic medications
• Previous thromboembolic event and/or known genetic predisposition
• Use of p.o. hormonal contraception
• Smoking
• BMI 18.5 - 25.0
• Age 18 - 50 years
• Female sex
• Somatic comorbidity requiring systemic medications
• Previous thromboembolic event and/or known genetic predisposition
• Use of p.o. hormonal contraception
• Smoking

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (5)

Clinical Pharmacology and Pharmacy, University of Southern Denmark

Odense, Fyn, 5000, Denmark

Location

Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark

Odense, Fyn, 5000, Denmark

Location

The Nutritional Unit, Department of Endocrinology, Center for Eating Disorders, Odense University Hospital and Psychiatry in the region of Southern Denmark

Odense, Fyn, 5220, Denmark

Location

Unit for Thrombosis Research, Department of Clinical Biochemistry, Hospital of South West Jutland

Esbjerg, Jylland, 6700, Denmark

Location

Department of Clinical Sciences, Umeå University

Umeå, Västerbotten County, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Anorexia Nervosa; Thrombosis; Thromboembolism; Insulin Resistance; Refeeding Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Malnutrition; Nutrition Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 12, 2022
• Study Start: November 15, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

DK (4); SE (1)