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

NCT06243536 | Unknown Phase 4

• 1 other identifier: 251-29-1 1/3-23-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Type 2 Diabetes; Overweight; Disordered Eating Behaviors

Keywords

Randomized controlled trial; Semaglutide; Incretin hormones; Glycemic variability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Continuous glucose monitoring parameter (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)

  At the beginning of the trial (before semaglutide administration)

Study Arms (3)

Type 2 diabetic patients without disordered eating behaviour

PLACEBO COMPARATOR

Treated with standard of care.

Drug: standard of care

Type 2 diabetic patients with disordered eating behaviour A

PLACEBO COMPARATOR

Treated with standard of care.

Drug: standard of care

Type 2 diabetic patients with disordered eating behaviour B

EXPERIMENTAL

Receiving semaglutide for 12 weeks

Drug: Semaglutide

Interventions

Semaglutide DRUG

Semaglutide will be administered through 12 weeks.

Type 2 diabetic patients with disordered eating behaviour B

standard of care DRUG

Patients not assigned to receive semaglutide will receive standard of care.

Also known as: Metformin, Sulfonylureas, Sodium-glucose cotransporter-2 inhibitors, pioglitazone

Type 2 diabetic patients with disordered eating behaviour A; Type 2 diabetic patients without disordered eating behaviour

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2 diabetes, age 18-65, BMI ≥28 kg/m2, HbA1c\>7%, glp-1 receptor agonist naïve

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead
• University of Zagreb School of Medicine: collaborator

Study Sites (1)

UH Sestre milosrdnice

Zagreb, 10000, Croatia

Location

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Related Links

• Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF diabetes atlas 10th ed. \[Internet\]. Brussels: International Diabetes Federation; 2021
• Buble T, Čavlina M. Nacionalni registar osoba sa šećernom bolešću CroDiab. Izvješće za 2022. \[Internet\]. Zagreb: Hrvatski zavod za javno zdravstvo; 2022
• U. S. Department of Agriculture, Agricultural Research Service. USDA National Nutrient Database for Standard Reference, Legacy Release. \[Internet\]. 2018

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Disordered Eating Behavior

Interventions

semaglutide; Standard of Care; Metformin; Sulfonylurea Compounds; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Biguanides; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds; Thiazolidinediones; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jelena Osmanović Barilar, Professor

  University of Zagreb School of Medicine

  STUDY CHAIR

Central Study Contacts

Jelena Marinković Radošević, MD

CONTACT

+385915719712; jelena.marinkovic1@gmail.com

Velimir Altabas, Assoc.Prof.

CONTACT

velimir.altabas@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Ivenstigator

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)