Type 2 DiabetesPhase 4NCT06243536
The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients
A Phase 4 study testing Semaglutide in people with Type 2 Diabetes and Overweight, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Overweight, Disordered Eating Behaviors
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Feb 2024to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes, age 18-65, BMI ≥28 kg/m2, HbA1c>7%, glp-1 receptor agonist naïve
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Velimir Altabas, Assoc.Prof. contact
Croatia1 site
UH Sestre milosrdnice
Zagreb, 10000
Jelena Marinković Radošević, MD, +385915719712, jelena.marinkovic1@gmail.com
About this study
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.
Read the 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 (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.
- Conditions
- Type 2 Diabetes, Overweight, Disordered Eating Behaviors
- Being tested
- Semaglutide, standard of care
- Keywords
- Randomized controlled trial, Semaglutide, Incretin hormones, Glycemic variability
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Disordered Eating Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide will be administered through 12 weeks.
standard of careDrug
Also called Metformin, Sulfonylureas, Sodium-glucose cotransporter-2 inhibitors, pioglitazone
Patients not assigned to receive semaglutide will receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic patients without disordered eating behaviour | Placebo comparator | Treated with standard of care. Receives: Drug: standard of care |
| Type 2 diabetic patients with disordered eating behaviour A | Placebo comparator | Treated with standard of care. Receives: Drug: standard of care |
| Type 2 diabetic patients with disordered eating behaviour B | Experimental | Receiving semaglutide for 12 weeks Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: At the beginning of the trial (before semaglutide administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Sestre Milosrdnice
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb
- Responsible party
- Principal investigator, Jelena Marinkovic Radosevic, University Hospital Sestre Milosrdnice
- Investigators
- Jelena Osmanović Barilar, Professor, Study chair, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243536
- Sponsor's protocol ID
- 251-29-1 1/3-23-06
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
PubMed 31518657Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.
PubMed 19336687Nieto-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.
PubMed 29168047Garcia-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.
PubMed 27575047Presseller 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.
PubMed 36305323Suh S, Kim JH. Glycemic Variability: How Do We Measure It and Why Is It Important? Diabetes Metab J. 2015 Aug;39(4):273-82. doi: 10.4093/dmj.2015.39.4.273.
PubMed 26301188Papelbaum 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.
PubMed 31516703Martinez 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.
PubMed 33762313Daly A, Hovorka R. Technology in the management of type 2 diabetes: Present status and future prospects. Diabetes Obes Metab. 2021 Aug;23(8):1722-1732. doi: 10.1111/dom.14418. Epub 2021 May 20.
PubMed 33950566Mancuso 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.
PubMed 25745131Nicolau 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.
PubMed 25841588Herpertz S, Albus C, Kielmann R, Hagemann-Patt H, Lichtblau K, Kohle K, Mann K, Senf W. Comorbidity of diabetes mellitus and eating disorders: a follow-up study. J Psychosom Res. 2001 Nov;51(5):673-8. doi: 10.1016/s0022-3999(01)00246-x.
PubMed 11728508Watts AG, Kanoski SE, Sanchez-Watts G, Langhans W. The physiological control of eating: signals, neurons, and networks. Physiol Rev. 2022 Apr 1;102(2):689-813. doi: 10.1152/physrev.00028.2020. Epub 2021 Sep 6.
PubMed 34486393Tong J, D'Alessio D. Eating disorders and gastrointestinal peptides. Curr Opin Endocrinol Diabetes Obes. 2011 Feb;18(1):42-9. doi: 10.1097/MED.0b013e328341e12b.
PubMed 21157325Smith 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.
PubMed 33989649
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Semaglutide on Disordered Eating Behaviour in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT06243536
- Acronym / sponsor ID
- 251-29-1 1/3-23-06
- Conditions
- Type 2 Diabetes, Overweight, Disordered Eating Behaviors
- Keywords
- Randomized controlled trial, Semaglutide, Incretin hormones, Glycemic variability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital Sestre MilosrdniceUniversity, hospital or other
- Collaborators
- University of Zagreb
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic patients without disordered eating behaviour | Placebo comparator | Drug: standard of careTreated with standard of care. |
| Type 2 diabetic patients with disordered eating behaviour A | Placebo comparator | Drug: standard of careTreated with standard of care. |
| Type 2 diabetic patients with disordered eating behaviour B | Experimental | Drug: SemaglutideReceiving semaglutide for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- type 2 diabetes, age 18-65, BMI ≥28 kg/m2, HbA1c>7%, glp-1 receptor agonist naïve
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide will be administered through 12 weeks. | Drug | Type 2 diabetic patients with disordered eating behaviour B |
| standard of careAlso: Metformin, Sulfonylureas, Sodium-glucose cotransporter-2 inhibitors, pioglitazonePatients not assigned to receive semaglutide will receive standard of care. | Drug | Type 2 diabetic patients with disordered eating behaviour A, Type 2 diabetic patients without disordered eating behaviour |
Primary outcome
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.
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.
2 secondary outcomes
Continuous glucose monitoring parameter (Glycemic Variability)
Time frame: 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)
Time frame: At the beginning of the trial (before semaglutide administration)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 31518657Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.
- Background: PubMed 19336687Defronzo RA. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009 Apr;58(4):773-95. doi: 10.2337/db09-9028. No abstract available.
- Background: PubMed 29168047Nieto-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.
- Background: PubMed 27575047Garcia-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.
- Background: PubMed 36305323Presseller 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.
- Background: PubMed 26301188Suh S, Kim JH. Glycemic Variability: How Do We Measure It and Why Is It Important? Diabetes Metab J. 2015 Aug;39(4):273-82. doi: 10.4093/dmj.2015.39.4.273.
- Background: PubMed 31516703Papelbaum 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.
- Background: PubMed 33762313Martinez 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.
- Background: PubMed 33950566Daly A, Hovorka R. Technology in the management of type 2 diabetes: Present status and future prospects. Diabetes Obes Metab. 2021 Aug;23(8):1722-1732. doi: 10.1111/dom.14418. Epub 2021 May 20.
- Background: PubMed 25745131Mancuso 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.
- Background: PubMed 25841588Nicolau 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.
- Background: PubMed 11728508Herpertz S, Albus C, Kielmann R, Hagemann-Patt H, Lichtblau K, Kohle K, Mann K, Senf W. Comorbidity of diabetes mellitus and eating disorders: a follow-up study. J Psychosom Res. 2001 Nov;51(5):673-8. doi: 10.1016/s0022-3999(01)00246-x.
- Magliano DJ, Boyko EJ; IDF Diabetes Atlas 10th edition scientific committee. IDF diabetes atlas 10th ed. \[Internet\]. Brussels: International Diabetes Federation; 2021Link provided by the sponsor.
- Buble T, Čavlina M. Nacionalni registar osoba sa šećernom bolešću CroDiab. Izvješće za 2022. \[Internet\]. Zagreb: Hrvatski zavod za javno zdravstvo; 2022Link provided by the sponsor.
- U. S. Department of Agriculture, Agricultural Research Service. USDA National Nutrient Database for Standard Reference, Legacy Release. \[Internet\]. 2018Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Velimir Altabas, Assoc.Prof. contact
Jelena Osmanović Barilar, Professor study chair
University of Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with Type 2 Diabetes and Overweight, run by University Hospital Sestre Milosrdnice at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jelena Marinković Radošević, MD (+385915719712, jelena.marinkovic1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06243536, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.