Type 2 Diabetes and Binge Eating Disorder (BED)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Better Treatment of Patients With Type 2 Diabetes and Binge Eating Disorder (BED)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325670
• Other study ID #: 23/50374
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Odense University Hospital
• Contact: Pernille Fiil Nybo, cand.psych.
• Phone: +45 2042 7108
• Email: pernille.fiil.nybo[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Feeding and Eating Disorders

Intervention

Behavioral:
• BED treatment
A 12 session cognitive behavioural intervention in groups for Danish adults with type 2 diabetes and Binge Eating Disorder.

Other:
• Waitlist
A waitlist control group that receives regular type 2 diabetes treatment while waiting to receive the BED treatment intervention.

Locations

Country	Name	City	State
Denmark	Region Of Southern Denmark Locations	Odense	Region Of Southern Denmark

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	Independent Research Fund Denmark, Jascha Fonden

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eating Disorder Examination Questionnaire (EDE-Q)	EDE-Q is a self-report questionnaire used to assess symptoms of eating disorders, particularly anorexia nervosa, bulimia nervosa, and Binge Eating Disorder (BED). It comprises various questions covering areas such as eating disorder symptoms, eating behaviors, and thoughts about body and weight. Participants complete the questionnaire to provide information about their eating patterns and body image.	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Other	Major Depression Inventory (MDI)	The Major Depression Inventory (MDI) is a self-report questionnaire designed to assess the presence and severity of symptoms of major depression. It consists of 10 questions covering various aspects of depression, such as mood, energy level, concentration, sleep patterns, and appetite changes. Participants respond to the questions using a 6-point Likert scale ranging from 0 to 5. The total score ranges from 0 to 50, with a higher score reflecting more symptoms of depression.	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Other	Problem Areas In Diabetes (PAID20)	PAID20 is a validated and extensively tested 20-item questionnaire that quantifies the emotional burden experienced by individuals with diabetes. This includes feelings of guilt, frustration, worry, and self-blame related to their diabetes. PAID questions are measured on a 5-point Likert scale with response options ranging from 0 to 4. PAID20 has demonstrated sensitivity to changes over time, making it suitable for evaluating the impact of therapeutic interventions and treatments in individuals with diabetes.	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Other	Lipid profile	Lipid profile assessments is measured as a blood sample (3 ml) and includes various blood lipid levels; cholesterol, triglycerides, and lipoproteins. Cholesterol levels, including HDL (high-density lipoprotein) and LDL (low-density lipoprotein), are evaluated to assess lipid metabolism and cardiovascular risk.	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Other	Body Mass Index (BMI)	BMI will be calculated as an outcome measure by combining weight (measured in kilograms) and height (measured in centimeters). BMI is calculated by dividing weight by the square of height. Participants are provided with blinded weighings, as weight loss is not the target of our intervention.	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Other	Blood Pressure	Blood pressure assessments will be conducted to evaluate cardiovascular health. Measurements will include systolic and diastolic pressures, recorded in millimeters of mercury (mmHg), to assess overall cardiovascular function and risk of cardiovascular disease	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Primary	Number of binge eating episodes	This outcome will assess changes in the number of binge eating episodes per week among participants receiving BED treatment compared to baseline	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks after for 7 days), and follow up (three months)
Secondary	Binge Eating Disorder Questionnaire	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.	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks), and follow up (three months)
Secondary	Glucose Sensor Data for Blood Glucose Profile	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.	Baseline (Days 0-7), post treatment/post waitlist (up to 20 weeks after for 7 days)
Secondary	HbA1c	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.	Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)