Type 2 Diabetes and Binge Eating Disorder (BED)

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Binge-Eating Disorder
• Interventions: Behavioral: BED treatment; Other: Waitlist

• Registration Number: NCT06325670
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2024-02-23
• Status Verified: 2024-03
• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BED treatment	BED treatment	The BED group therapy program consists of 11 sessions, followed by a 3-month follow-up session. Each 3-hour session accommodates eight patients and two psychologists. Treatment follows a manualized cognitive behavioral therapy approach, with patients receiving a complimentary manual at the start. Sessions are conducted both in-person and online using a blended care model, with about one-third delivered virtually.
Waitlist	Waitlist	The waitlist control group consists of participants who are placed on a waiting list to receive treatment. While participants in the treatment group immediately receive BED treatment (Arm 1), those in the waitlist control group do not receive active treatment initially. They remain on the waiting list for 6 months until the treatment group completes their intervention. At that point, participants in the waitlist control group also receive the same BED treatment, serving as a comparison group to evaluate the intervention's effectiveness.

Primary Outcome Measures

Name	Time	Method
Number of binge eating episodes	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks after for 7 days), and follow up (three months)	This outcome will assess changes in the number of binge eating episodes per week among participants receiving BED treatment compared to baseline

Secondary Outcome Measures

Name	Time	Method
HbA1c	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)	HbA1c, or glycated hemoglobin, levels are measured as a blood sample (2 ml) to assess long-term blood sugar control. This measure reflects average blood glucose levels over the past two to three months, and lower HbA1c levels indicate better glycemic control.
Binge Eating Disorder Questionnaire	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks), and follow up (three months)	BED-Q is a questionnaire consisting of 10 items, with questions 1-7 assessed on a Likert scale from 0-5. Together, these questions constitute a score ranging from 0-35, indicating the severity of Binge Eating Disorder (BED) from none to mild, moderate, severe, and extreme. The items in BED-Q are carefully crafted to reflect the diagnostic criteria for Binge Eating Disorder (BED) according to DSM-5, including (1) episodes of binge eating large amounts of food in a short period (within two hours); (2) a sense of losing control over eating; (3) eating faster than usual; (4) eating until uncomfortably full; (5) eating when not hungry; (6) eating alone; and (7) experiencing negative emotions such as guilt or shame after binge eating. Question 8 is used to screen for any compensatory behaviors, such as vomiting, while questions 9 and 10 examine the distress associated with binge eating episodes.
Glucose Sensor Data for Blood Glucose Profile	Baseline (Days 0-7), post treatment/post waitlist (up to 20 weeks after for 7 days)	Glucose sensor data will be collected using continuous glucose monitoring devices to assess blood glucose profiles during the first week and the last week of the treatment period. This non-invasive method captures real-time glucose levels over time, providing insights into glucose variability and trends. The collected data will aid in evaluating the effectiveness of the intervention in managing blood glucose levels and overall glycemic control.

Trial Locations

Locations (1)

Region Of Southern Denmark Locations; 🇩🇰 Odense, Region Of Southern Denmark, Denmark