Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06325670
Study type Interventional
Source Odense University Hospital
Contact Pernille Fiil Nybo, cand.psych.
Phone +45 2042 7108
Email pernille.fiil.nybo@rsyd.dk
Status Recruiting
Phase N/A
Start date February 23, 2024
Completion date June 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2