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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243536
• Other study ID #: 251-29-1 1/3-23-06
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University Hospital "Sestre Milosrdnice"
• Contact: Jelena Marinkovic Radoševic, MD
• Phone: +385915719712
• Email: jelena.marinkovic1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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.

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 (1:1), in group with disordered eating behaviour (n=30) if participants scored >20 points, and group without disordered eating behaviour (n=30) if participants scored ≤20 points. Group of patients with disordered eating behaviour will be further randomized whether participants will receive semaglutide (n=15) with standard care or if participants will be treated with standard care (n=15). 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 exposure*time interactions. Type I (α) error=0.05.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Disordered Eating Behaviors
• Overweight
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Croatia	UH Sestre milosrdnice	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital "Sestre Milosrdnice"	University of Zagreb School of Medicine

Country where clinical trial is conducted

Croatia, 

References & Publications (38)

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* Note: There are 38 references in all — Click here to view all references

Outcome

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)

External Links

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