The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients

Sponsor
University Hospital Sestre Milosrdnice
Study ID
NCT06243536
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Semaglutide will be administered through 12 weeks.
  • standard of care — DRUG
    Patients not assigned to receive semaglutide will receive standard of care.

Study Details

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.

Key Dates

Start date
Feb 1, 2024
Status verified
Jan 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Type 2 diabetic patients without disordered eating behaviour
    Treated with standard of care.
  • Placebo Comparator: Type 2 diabetic patients with disordered eating behaviour A
    Treated with standard of care.
  • Experimental: Type 2 diabetic patients with disordered eating behaviour B
    Receiving semaglutide for 12 weeks

Primary Outcome Measure

Eating Attitude Test (EAT-26) questionnaire score [ Time Frame: EAT-26 questionnaire will be assessed at the beginning of the trial and at the end of the trial after 12 weeks. ]

Central Contacts

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