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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06243536
Other study ID # 251-29-1 1/3-23-06
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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Garcia-Mayor RV, Garcia-Soidan FJ. Eating disoders in type 2 diabetic people: Brief review. Diabetes Metab Syndr. 2017 Jul-Sep;11(3):221-224. doi: 10.1016/j.dsx.2016.08.004. Epub 2016 Aug 22. — View Citation

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Hsu TM, Noble EE, Liu CM, Cortella AM, Konanur VR, Suarez AN, Reiner DJ, Hahn JD, Hayes MR, Kanoski SE. A hippocampus to prefrontal cortex neural pathway inhibits food motivation through glucagon-like peptide-1 signaling. Mol Psychiatry. 2018 Jul;23(7):1555-1565. doi: 10.1038/mp.2017.91. Epub 2017 May 2. — View Citation

Jensterle M, Kocjan T, Kravos NA, Pfeifer M, Janez A. Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome. Endocr Res. 2015;40(3):133-8. doi: 10.3109/07435800.2014.966385. Epub 2014 Oct 20. — View Citation

Mancuso SG, Newton JR, Bosanac P, Rossell SL, Nesci JB, Castle DJ. Classification of eating disorders: comparison of relative prevalence rates using DSM-IV and DSM-5 criteria. Br J Psychiatry. 2015 Jun;206(6):519-20. doi: 10.1192/bjp.bp.113.143461. Epub 2015 Mar 5. — View Citation

Martinez M, Santamarina J, Pavesi A, Musso C, Umpierrez GE. Glycemic variability and cardiovascular disease in patients with type 2 diabetes. BMJ Open Diabetes Res Care. 2021 Mar;9(1):e002032. doi: 10.1136/bmjdrc-2020-002032. — View Citation

McElroy SL, Mori N, Guerdjikova AI, Keck PE Jr. Would glucagon-like peptide-1 receptor agonists have efficacy in binge eating disorder and bulimia nervosa? A review of the current literature. Med Hypotheses. 2018 Feb;111:90-93. doi: 10.1016/j.mehy.2017.12.029. Epub 2018 Jan 2. — View Citation

Meier JJ. Efficacy of Semaglutide in a Subcutaneous and an Oral Formulation. Front Endocrinol (Lausanne). 2021 Jun 25;12:645617. doi: 10.3389/fendo.2021.645617. eCollection 2021. — View Citation

Nauck MA, Quast DR, Wefers J, Meier JJ. GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art. Mol Metab. 2021 Apr;46:101102. doi: 10.1016/j.molmet.2020.101102. Epub 2020 Oct 14. — View Citation

Nicolau J, Simo R, Sanchis P, Ayala L, Fortuny R, Zubillaga I, Masmiquel L. Eating disorders are frequent among type 2 diabetic patients and are associated with worse metabolic and psychological outcomes: results from a cross-sectional study in primary and secondary care settings. Acta Diabetol. 2015 Dec;52(6):1037-44. doi: 10.1007/s00592-015-0742-z. Epub 2015 Apr 5. — View Citation

Nieto-Martinez R, Gonzalez-Rivas JP, Medina-Inojosa JR, Florez H. Are Eating Disorders Risk Factors for Type 2 Diabetes? A Systematic Review and Meta-analysis. Curr Diab Rep. 2017 Nov 22;17(12):138. doi: 10.1007/s11892-017-0949-1. — View Citation

Papelbaum M, de Oliveira Moreira R, Coutinho WF, Kupfer R, Freitas S, Raggio Luz R, Appolinario JC. Does binge-eating matter for glycemic control in type 2 diabetes patients? J Eat Disord. 2019 Sep 6;7:30. doi: 10.1186/s40337-019-0260-4. eCollection 2019. — View Citation

Pratley RE, Catarig AM, Lingvay I, Viljoen A, Paine A, Lawson J, Chubb B, Gorst-Rasmussen A, Miresashvili N. An indirect treatment comparison of the efficacy of semaglutide 1.0 mg versus dulaglutide 3.0 and 4.5 mg. Diabetes Obes Metab. 2021 Nov;23(11):2513-2520. doi: 10.1111/dom.14497. Epub 2021 Aug 9. — View Citation

Presseller EK, Patarinski AGG, Zhang F, Page KA, Srivastava P, Manasse SM, Juarascio AS. Glucose variability: A physiological correlate of eating disorder behaviors among individuals with binge-spectrum eating disorders. Int J Eat Disord. 2022 Dec;55(12):1788-1798. doi: 10.1002/eat.23838. Epub 2022 Oct 28. — View Citation

Rahelic D, Altabas V, Bakula M, Balic S, Balint I, Markovic BB, Bicanic N, Bjelinski I, Bozikov V, Varzic SC, Car N, Berkovic MC, Orlic ZC, Deskin M, Sunic ED, Tomic NG, Goldoni V, Gradiser M, Mahecic DH, Balen MJ, Erzen DJ, Majanovic SK, Kokic' S, Krnic M, Kruljac I, Liberati-Cizmek AM, Martina L, Metelko Z, Mirosevic G, Vrbica SM, Renar IP, Petric D, Prasek M, Prpic-Kizevac I, Radman M, Soldo D, Saric T, Tesanovic S, Kurir TT, Wensveen TT, Botica M, Vrkljan M, Rotkvic VZ, Zoric C, Krznaric Z. [CROATIAN GUIDELINES FOR THE PHARMACOTHERAPY OF TYPE 2 DIABETES]. Lijec Vjesn. 2016 Jan-Feb;138(1-2):1-21. Croatian. — View Citation

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Smith KR, Moran TH. Gastrointestinal peptides in eating-related disorders. Physiol Behav. 2021 Sep 1;238:113456. doi: 10.1016/j.physbeh.2021.113456. Epub 2021 May 11. — View Citation

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Takahashi Y, Nomoto H, Yokoyama H, Takano Y, Nagai S, Tsuzuki A, Cho KY, Miya A, Kameda H, Takeuchi J, Taneda S, Kurihara Y, Atsumi T, Nakamura A, Miyoshi H; SWITCH-SEMA 1 study group. Improvement of glycaemic control and treatment satisfaction by switching from liraglutide or dulaglutide to subcutaneous semaglutide in patients with type 2 diabetes: A multicentre, prospective, randomized, open-label, parallel-group comparison study (SWITCH-SEMA 1 study). Diabetes Obes Metab. 2023 Jun;25(6):1503-1511. doi: 10.1111/dom.14998. Epub 2023 Feb 28. — View Citation

Tommerdahl KL, Nadeau KJ, Bjornstad P. Mechanisms of Cardiorenal Protection of Glucagon-Like Peptide-1 Receptor Agonists. Adv Chronic Kidney Dis. 2021 Jul;28(4):337-346. doi: 10.1053/j.ackd.2021.06.001. — View Citation

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* Note: There are 38 references in allClick 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)
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