| Trial ID: | L4520 |
| Source ID: | NCT06243536
|
| Associated Drug: |
Semaglutide
|
| Title: |
The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes|Overweight|Disordered Eating Behaviors
|
| Interventions: |
DRUG: Semaglutide|DRUG: standard of care
|
| Outcome Measures: |
Primary: Eating Attitude Test (EAT-26) questionnaire score, Investigate the effect of semaglutide on the intensity of disordered eating behaviour quantified by the EAT-26 questionnaire in patients with overweight and type 2 diabetes. Possible scores in EAT-26 questionnaire min.0-max 78, with lower score indicating better outcome., EAT-26 questionnaire will be assessed at the beginning of the trial and at the end of the trial after 12 weeks. | Secondary: Continuous glucose monitoring parameter (Glycemic Variability), Investigate the effect of semaglutide on continuous glucose monitoring parameter glycemic variability defined by the measurement of fluctuations of glucose over a given interval of time (14 days) presented as coefficient of variation (CV) with values of %CV ≥ 36, as high glycemic variability., CGM parameter will be assessed through 14 days at the beginning of the trial and through 14 days at the end of the trial after 12 weeks.|Concentration of incretin hormones (GLP-1, GIP), To assess the concentrations of incretin hormones (GLP-1, GIP) in group of participants with eating behaviour disorder and in group of participants without eating behaviour disorder., At the beginning of the trial (before semaglutide administration)
|
| Sponsor/Collaborators: |
Sponsor: University Hospital Sestre Milosrdnice | Collaborators: University of Zagreb School of Medicine
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-02-01
|
| Completion Date: |
2024-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-06
|
| Locations: |
UH Sestre milosrdnice, Zagreb, 10000, Croatia
|
| URL: |
https://clinicaltrials.gov/show/NCT06243536
|
