Thromboembolism in Anorexia Nervosa

Completed

• Conditions: Thrombosis; Anorexia Nervosa; Thromboembolism
• Interventions: Diagnostic Test: Blood samples; Diagnostic Test: Questionnaires

• Registration Number: NCT05575466
• Lead Sponsor: Odense University Hospital

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.

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

1. Is the incidence of venous and arterial thromboembolism increased in patients diagnosed with AN compared to an age-matched control group?

2. Is the hemostatic balance disturbed in women with AN compared with healthy, normal-weight women?

3. 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 Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-12
• Study Start: 2022-11-15
• Status Verified: 2024-10
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Questionnaires	Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed
Patients	Blood samples	Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed
Controls	Blood samples	Will have thromboembolic incidence rate evaluated and will have a battery of hemostatic markers analyzed

Primary Outcome Measures

Name	Time	Method
Incidence of thromboembolic events	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.

Trial Locations

Locations (5)

Clinical Pharmacology and Pharmacy, University of Southern Denmark; 🇩🇰 Odense, Fyn, Denmark

Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark; 🇩🇰 Odense, Fyn, Denmark

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

Unit for Thrombosis Research, Department of Clinical Biochemistry, Hospital of South West Jutland; 🇩🇰 Esbjerg, Jylland, Denmark

Department of Clinical Sciences, Umeå University; 🇸🇪 Umeå, Västerbotten, Sweden