Type 2 Diabetes and Binge Eating Disorder (BED)

NCT06325670 | Completed

• 1 other identifier: 23/50374
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Binge-Eating Disorder

Keywords

BED; T2D; Treatment; Binge Eating Disorder; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Binge Eating Disorder Questionnaire

  Baseline (Day 0), post treatment/post waitlist (up to 20 weeks), and follow up (three months)

• Glucose Sensor Data for Blood Glucose Profile

  Baseline (Days 0-7), post treatment/post waitlist (up to 20 weeks after for 7 days)

• HbA1c

  Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)

Other Outcomes (6)

• Eating Disorder Examination Questionnaire (EDE-Q)

  Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)

• Major Depression Inventory (MDI)

  Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)

• Problem Areas In Diabetes (PAID20)

  Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)

Study Arms (2)

BED treatment

EXPERIMENTAL

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.

Behavioral: BED treatment

Waitlist

OTHER

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.

Other: Waitlist

Interventions

BED treatment BEHAVIORAL

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

BED treatment

Waitlist OTHER

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

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead
• Jascha Fonden: collaborator
• Independent Research Fund Denmark: collaborator

Study Sites (1)

Region Of Southern Denmark Locations

Odense, Region Syddanmark, 5000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Binge-Eating Disorder; Diabetes Mellitus

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Pernille Fiil Nybo, cand.psych.

  University og Southern Denmark, SDU

  PRINCIPAL INVESTIGATOR

• Jakob Linnet, Dr.med., cand.psych.

  Occupational- and Environmental Clinic, OUH

  PRINCIPAL INVESTIGATOR

• Michael Roeder, Dr.med.

  Steno Diabetes Center Odense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 22, 2024
• Study Start: February 23, 2024
• Primary Completion: April 2, 2025
• Study Completion: February 3, 2026
• Last Updated: February 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)