Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243536
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-13
Brief Title:
The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients
Sponsor:
University Hospital Sestre Milosrdnice
Organization:
University Hospital Sestre Milosrdnice
Study Overview
Official Title:
The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 11 Patients with a disordered eating behaviour will further be randomized 11 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
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 11 Patients with a disordered eating behaviour will further be randomized 11 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
Detailed Description:
This randomized controlled trial will be conducted in Clinical Hospital Center Sestre milosrdnice and University of Zagreb School of medicine Patients will be randomized after completing the EAT-26 questionnaire 11 in group with disordered eating behaviour n30 if participants scored 20 points and group without disordered eating behaviour n30 if participants scored 20 points Group of patients with disordered eating behaviour will be further randomized whether participants will receive semaglutide n15 with standard care or if participants will be treated with standard care n15 The investigators will evaluate baseline EAT-26 score GLP-1 and GIP blood levels in a mixed meal test anthropometric measurements weight BMI waist circumference biochemical parameters complete blood count glucose insulin c-peptide HbA1c urea creatinine uric acid aspartate aminotransferase AST alanine aminotransferase ALT gamma-glutamyltransferase GGT international normalized ratio INR albumin serum lipid levels cholesterol HDL LDL triglyceride C reactive protein CRP urine sediment and their changes at the end of the trial except mixed meal test Also through 14 days at the beginning and 14 days before the end of the trial patients will keep a food diary and have intermittently scanned continuous glucose monitor FreeStyle Libre Pro CGM device Abbott
A factor analysis of EAT-26 scores will be conducted to form 3 expected latent variables components To assess the effect on dietary habits the difference in EAT-26 total score and latent variables between subjects randomized to semaglutide and control subjects randomized to standard care will be assessed after 3 months of treatment The data will be analysed in a general linear model with basal covariates age sex BMI and score at the beginning of treatment In the same way the effect of semaglutide on GLP1 concentrations basal covariate basal concentration next to the location of the EAT-26 score will be evaluated separately for the condition before and after the mixed meal test GLP-1 and GIP concentrations will be compared between subjects with exposed and without control eating disorders in a generalized linear model for repeated measurements GLP-1 concentration before and after mixed meal test with fixed covariates age sex BMI time before or after mixed meal test and exposuretime interactions Type I α error005
A factor analysis of EAT-26 scores will be conducted to form 3 expected latent variables components To assess the effect on dietary habits the difference in EAT-26 total score and latent variables between subjects randomized to semaglutide and control subjects randomized to standard care will be assessed after 3 months of treatment The data will be analysed in a general linear model with basal covariates age sex BMI and score at the beginning of treatment In the same way the effect of semaglutide on GLP1 concentrations basal covariate basal concentration next to the location of the EAT-26 score will be evaluated separately for the condition before and after the mixed meal test GLP-1 and GIP concentrations will be compared between subjects with exposed and without control eating disorders in a generalized linear model for repeated measurements GLP-1 concentration before and after mixed meal test with fixed covariates age sex BMI time before or after mixed meal test and exposuretime interactions Type I α error005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None