Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2024-02-23
2026-02-03
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
BED treatment
A 12 session cognitive behavioural intervention in groups for Danish adults with type 2 diabetes and Binge Eating Disorder.
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.
Waitlist
A waitlist control group that receives regular type 2 diabetes treatment while waiting to receive the BED treatment intervention.
Interventions
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BED treatment
A 12 session cognitive behavioural intervention in groups for Danish adults with type 2 diabetes and Binge Eating Disorder.
Waitlist
A waitlist control group that receives regular type 2 diabetes treatment while waiting to receive the BED treatment intervention.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Jascha Fonden
OTHER
Independent Research Fund Denmark
INDUSTRY
Odense University Hospital
OTHER
Responsible Party
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Principal Investigators
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Pernille Fiil Nybo, cand.psych.
Role: PRINCIPAL_INVESTIGATOR
University og Southern Denmark, SDU
Jakob Linnet, Dr.med., cand.psych.
Role: PRINCIPAL_INVESTIGATOR
Occupational- and Environmental Clinic, OUH
Michael Roeder, Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Steno Diabetes Center Odense
Locations
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Region Of Southern Denmark Locations
Odense, Region Syddanmark, Denmark
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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23/50374
Identifier Type: -
Identifier Source: org_study_id
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