Clinical trial NCT06325670: Type 2 Diabetes and Binge Eating Disorder (BED)
Official title: Better Treatment of Patients With Type 2 Diabetes and Binge Eating Disorder (BED)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Binge-Eating Disorder
Keywords: BED
T2D
Treatment
Binge Eating Disorder
Diabetes
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Jascha Fonden
name: Independent Research Fund Denmark
First posted: 2024-03-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research project is to improve the treatment of individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). The research hypothesizes that BED treatment will not only improve BED symptoms but also improve T2D severity and associated cardiovascular risk factors. The research involves a multidisciplinary team, including experts in endocrinology, psychology, and eating disorders.

The main questions it aims to answer are:

* Does treatment for Binge Eating Disorder lead to improvements in BED symptoms?
* Does treatment for Binge Eating Disorder lead to improvements in T2D severity and associated cardiovascular risk factors?

Participants will undergo a comprehensive treatment program targeting both BED and T2D. This program will include psychotherapy sessions focusing on cognitive-behavioral techniques to address binge eating behavior.

Researchers will compare participants' outcomes before and after the treatment program to assess changes in BED symptoms, T2D severity, and associated cardiovascular risk factors.

Detailed description: This research project aims to address the treatment challenges faced by individuals living with both type 2 diabetes (T2D) and Binge Eating Disorder (BED). It is estimated that approximately 300,000 people in Denmark have T2D, while 40-50,000 adults suffer from BED. The prevalence of BED among patients with T2D is up to 20%, and individuals with T2D and BED often experience more somatic and psychological symptoms compared to those with T2D alone.

The primary objective of this project is to improve the treatment outcomes for patients with coexisting T2D and BED. To achieve this, the project has three specific aims:

1. Prevalence assessment: The project aims to identify the prevalence of BED within a cohort of approximately 4,000 patients diagnosed with T2D in the Region of Southern Denmark. This cohort is part of the DD2 cohort, managed by the Danish Center for Strategic Research in Type 2 Diabetes.
2. Treatment efficacy investigation: The project will conduct a Randomized Controlled Trial (RCT) involving 64 patients diagnosed with both T2D and BED. The trial will investigate the effects of BED treatment on various outcomes, including changes in BED symptoms, glycemic control, and associated cardiovascular risk factors.
3. Glucose sensor study: Patients will be assessed using continuous glucose monitoring sensors for a week before and after pre- and post-test visits at Odense University Hospital (OUH). This allows for detailed blood glucose profiles without finger pricking. Data on time in range, time below range, variability, and area under the curve will be extracted from the sensors. These data aim to provide insights into glycemic variability, complementing traditional HbA1c measurements and aiding in evaluating the intervention's effectiveness.

By addressing these aims, the project seeks to enhance the understanding of the prevalence of BED among individuals with T2D and evaluate the efficacy of BED treatment interventions in improving health outcomes for this patient population.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* A diagnosis of mild to severe BED based on thorough assessment
* Sufficient ability to communicate in Danish
* Ability to sit on a chair for up to 3 hours

Exclusion Criteria:

* Previously diagnosed with autism spectrum disorder or psychotic disorders
* Dementia or developmental disability.
* Severe anxiety or depression or personality disorder assessed through clinical interview with SCID (based on DSM-V criteria)
* Currently experiencing severe to moderate substance abuse

Use of weight loss medication is not an exclusion criterion but is clearly noted regarding the results.

Primary outcomes:
measure: Number of binge eating episodes
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks after for 7 days), and follow up (three months)
Secondary outcomes:
measure: Binge Eating Disorder Questionnaire
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks), and follow up (three months)
measure: Glucose Sensor Data for Blood Glucose Profile
timeFrame: Baseline (Days 0-7), post treatment/post waitlist (up to 20 weeks after for 7 days)
measure: HbA1c
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Other outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
measure: Major Depression Inventory (MDI)
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
measure: Problem Areas In Diabetes (PAID20)
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
measure: Lipid profile
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
measure: Body Mass Index (BMI)
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
measure: Blood Pressure
timeFrame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Locations:
city: Odense
country: Denmark
facility: Region Of Southern Denmark Locations
state: Region Of Southern Denmark
Study officials:
affiliation: University og Southern Denmark, SDU
name: Pernille Fiil Nybo, cand.psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Occupational- and Environmental Clinic, OUH
name: Jakob Linnet, Dr.med., cand.psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Odense
name: Michael Roeder, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: