Type 2 Diabetes Clinical Trial
Official title:
The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients
The aim of this study is to evaluate the effect of glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide on disordered eating behaviour in patients with overweight and type 2 diabetes. The investigators will also evaluate serum concentrations of incretin hormones GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), as well as glucose variability using continuous glucose monitoring (CGM) devices before and after semaglutide, and determine his influence on eating disorders. In this prospective study the investigators aim to recruit 60 patients with type 2 diabetes and randomize them based on the presence of a disordered eating behaviour diagnosed by a validated questionnaire (1:1). Patients with a disordered eating behaviour will further be randomized (1:1) to receive semaglutide. At baseline and after 12 weeks of semaglutide therapy, the investigators will reevaluate glucose variability over 14 days using a continuous glucose monitoring device (CGM). With this study the investigators will determine the impact of GLP-1 receptor agonist semaglutide on disordered eating behaviour in patients with overweight and type 2 diabetes. This study will contribute to the knowledge about the role of incretin hormones and glucose variability in eating disorders in this population of patients.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - type 2 diabetes, age 18-65, BMI =28 kg/m2, HbA1c>7%, glp-1 receptor agonist naïve Exclusion Criteria: - hepatic impairment (Child Pugh score C), renal impairment (eGFR<30 ml/min), use of medication that affect eating (GLP-1 receptor agonists, antidepressants, antiobesity medications, glucocorticoids, insulin, oral contraceptives, hormonal therapy), conditions that can affect eating (hypothyroidism, hyperthyroidism, Cushing syndrome, acromegaly, adrenal insufficiency, pregnancy, breastfeeding), contraindications for semaglutide |
Country | Name | City | State |
---|---|---|---|
Croatia | UH Sestre milosrdnice | Zagreb |
Lead Sponsor | Collaborator |
---|---|
University Hospital "Sestre Milosrdnice" | University of Zagreb School of Medicine |
Croatia,
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* Note: There are 38 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | |
Secondary | 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) |
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