Diabetes Mellitus, Type 2NCT06325670
Type 2 Diabetes and Binge Eating Disorder (BED)
A study testing BED treatment and Waitlist in people with Diabetes Mellitus, Type 2 and Binge-Eating Disorder, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Binge-Eating Disorder
- What is being tested?
- BED treatment and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Feb 2024to 3 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Region Of Southern Denmark Locations
Odense, Region Syddanmark, 5000
About this study
Official title: Better Treatment of Patients With Type 2 Diabetes and Binge Eating Disorder (BED)
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:
Read more
- 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.
Read the 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:
- 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.
- 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.
- 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
- Diabetes Mellitus, Type 2, Binge-Eating Disorder
- Being tested
- BED treatment, Waitlist
- Keywords
- BED, T2D, Treatment, Binge Eating Disorder, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Binge-Eating Disorder, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BED treatmentBehavioural
A 12 session cognitive behavioural intervention in groups for Danish adults with type 2 diabetes and Binge Eating Disorder.
WaitlistOther
A waitlist control group that receives regular type 2 diabetes treatment while waiting to receive the BED treatment intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks), and follow up (three months)
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.
Measured: Baseline (Days 0-7), post treatment/post waitlist (up to 20 weeks after for 7 days)
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.
Measured: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start23 Feb 2024
- Primary completion2 Apr 2025
- Study completion3 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jascha Fonden, Independent Research Fund Denmark
- Responsible party
- Sponsor
- Investigators
- Pernille Fiil Nybo, cand.psych., Principal investigator, University og Southern Denmark, SDUJakob Linnet, Dr.med., cand.psych., Principal investigator, Occupational- and Environmental Clinic, OUHMichael Roeder, Dr.med., Principal investigator, Steno Diabetes Center Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325670
- Sponsor's protocol ID
- 23/50374
- Status last verified
- Jul 2025
- First submitted
- 1 Mar 2024
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Treatment of Patients With Type 2 Diabetes and Binge Eating Disorder (BED)
- ClinicalTrials.gov ID
- NCT06325670
- Acronym / sponsor ID
- 23/50374
- Conditions
- Diabetes Mellitus, Type 2, Binge-Eating Disorder
- Keywords
- BED, T2D, Treatment, Binge Eating Disorder, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Jascha Fonden, Independent Research Fund Denmark
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 3 Feb 2026 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BED treatment | Experimental | Behavioral: BED treatmentThe 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 | Other | Other: WaitlistThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BED treatmentA 12 session cognitive behavioural intervention in groups for Danish adults with type 2 diabetes and Binge Eating Disorder. | Behavioural | BED treatment |
| WaitlistA waitlist control group that receives regular type 2 diabetes treatment while waiting to receive the BED treatment intervention. | Other | Waitlist |
Primary outcome
Number of binge eating episodes
Time frame: 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
3 secondary outcomes
Binge Eating Disorder Questionnaire
Time frame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks), and follow up (three months)
Glucose Sensor Data for Blood Glucose Profile
Time frame: Baseline (Days 0-7), post treatment/post waitlist (up to 20 weeks after for 7 days)
HbA1c
Time frame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille Fiil Nybo, cand.psych. principal investigator
University og Southern Denmark, SDU
Jakob Linnet, Dr.med., cand.psych. principal investigator
Occupational- and Environmental Clinic, OUH
Michael Roeder, Dr.med. principal investigator
Steno Diabetes Center Odense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BED treatment and Waitlist in people with Diabetes Mellitus, Type 2 and Binge-Eating Disorder, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of binge eating episodes (time frame: Baseline (Day 0), post treatment/post waitlist (up to 20 weeks after for 7 days), and follow up (three months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.