Impact of Eating Disorders

NCT07534059 | Completed

• 2 other identifiers: 2022/059/OB2022-A00705-38
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Eating disorders (EDs), as classified by the American Psychiatric Association's DSM-5, have an estimated lifetime prevalence of 0.6% in the Caucasian adult population, with a male-to-female ratio of 1:8, and begin in 84% to 87% of cases between the ages of 15 and 25. Anorexia nervosa (AN) is an eating disorder that represents a significant public health concern due to its impact on long-term morbidity and mortality. The incidence of AN is steadily increasing in many countries, particularly in France, with a prevalence of 2-3% among adolescents and young adults. A 10-year mortality rate of 5-10% has been reported, making AN the psychiatric disorder with the highest mortality rate. This predominantly female disorder (female-to-female ratio of 1:9) is defined by the persistent association of disordered eating behavior, distorted body image, and obsessions with weight and food, with detrimental health consequences. Anorexia nervosa (AN) exposes patients to numerous somatic and neuropsychiatric complications, which are poor prognostic factors. Its etiopathogenesis is multifactorial and involves environmental, psychological, genetic, and sociocultural factors. Bulimia nervosa (BN) is also associated with an intense fear of gaining weight. There is a disturbance of body image characterized by profound dissatisfaction with weight and physical appearance. BN is characterized by binge-eating episodes (consuming a large amount of food in a short period of time, associated with a feeling of loss of control) followed by inappropriate compensatory behaviors such as self-induced vomiting, misuse of laxatives, diuretics, or other medications; fasting; and excessive exercise. Individuals with bulimia nervosa generally have a subnormal body mass index (BMI), making diagnosis more difficult. Type 1 diabetes is an autoimmune disease characterized by the destruction of the beta cells of the pancreatic islets of Langerhans, leading to a deficiency in insulin secretion. Generally, the diagnosis is made in childhood or adolescence, but late-diagnosed forms exist, forming an entity called latent autoimmune diabetes in adults (LADA), also known as type 1 diabetes. Diagnosis is made by measuring antibodies specific to type 1 diabetes: anti-GAD and anti-IA2 antibodies as the first-line tests, and anti-ZnT8 antibodies as a second-line test. Drug treatment primarily relies on continuous insulin administration via multiple daily injections or an insulin pump. Nutritional management is a cornerstone of treatment, playing a crucial role in glycemic control and the prevention of metabolic complications. "Diabulimia" is a recent term describing a specific eating disorder in patients with type 1 diabetes. It is characterized by a voluntary restriction of insulin administration for the purpose of weight loss, at the expense of optimal glycemic control. This condition involves several complex factors (such as insulin injection, capillary blood glucose, emotions, and body image) that link diabetes management to the patient's mental health. "Diabulimia" is not yet recognized as a distinct medical entity, lacks precise diagnostic criteria, and is difficult to detect. However, the serious consequences it entails, such as diabetic ketoacidosis in the short term and the chronic complications of hyperglycemia in the long term, make its screening essential.

Conditions

Eating Disorders in Adolescence

Keywords

type 1 diabetic patients

Outcome Measures

Primary Outcomes (1)

• Evaluation of the impact of TCA on the glycemic profile of patients with type 1 diabetes

  The main objective of the study is to evaluate the impact of TCA on the glycemic profile of patients with type 1 diabetes. Time spent in and above target glycemic range over the past 3 months will be assessed in patients with an eating disorder (ED).

  3 months

Secondary Outcomes (8)

• Evaluate the impact of TCA in type 1 diabetic patients on HbA1c measurement

  1 day

• Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (GMI (glucose management indicator))

  1 day

• Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (microangiopathic (diabetic retinopathy))

  3 months

• Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (microangiopathic (diabetic neuropathy))

  3 months

• Evaluate the impact of TCA in type 1 diabetic patients on complications of diabetes (microangiopathic (diabetic nephropathy))

  3 months

Study Arms (2)

Evaluate the impact of TCA on the glycemic profile of type 1 diabetic patients with eating disorder

Correlation of self-documented questionnaires completed by the patient (J0) and data from CGM devices over the last 3 months collected by the diabetologist, as part of care.

Evaluate the impact of TCA on the glycemic profile of type 1 diabetic patients without eating disord

Correlation of self-documented questionnaires completed by the patient (J0) and data from CGM devices over the last 3 months collected by the diabetologist, as part of care.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

type 1 diabetic patients

You may qualify if:

• Female patients
• Patients aged 18 to 40 years
• Patients diagnosed with type 1 diabetes (positive for anti-GAD, anti-IA2, and anti-ZnT8 antibodies)
• Patients on insulin therapy alone (basal-bolus regimen or insulin pump)
• Patients using a continuous glucose monitoring device such as an FSL or DEXCOM
• Patients followed in the clinical nutrition and/or diabetology department of the Rouen University Hospital and the Le Havre Hospital
• Social security coverage
• Patients who have agreed to participate in the study

You may not qualify if:

• Patients taking antidiabetic medication other than insulin therapy alone
• Patients with limited understanding of spoken or written French
• Individuals deprived of their liberty by an administrative or judicial decision, or individuals subject to legal protection measures for adults
• Individuals under guardianship, conservatorship, or other protective supervision
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

Location

Study Officials

• NAJATE NA ACHAMRAH, Professor

  University Rouen Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 16, 2026
• Study Start: June 10, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 1, 2024
• Last Updated: April 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)