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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT06243536 (opens ClinicalTrials.gov in a new tab)Other id251-29-1 1/3-23-06
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
60 participants (estimated)
Sponsor
University Hospital Sestre Milosrdnice · Other
Design
Randomized · Single masking
Countries
1 country

Croatia

Start
1 Feb 2024 (estimated)
Primary completion
31 Dec 2024 (estimated)
Completion
31 Dec 2024 (estimated)
First posted
6 Feb 2024
Last update posted
6 Feb 2024
Conditions
Type 2 Diabetes · Overweight · Disordered Eating Behaviors

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025
  1. Ph 4

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

    NCT06243536

    est. 1 Feb 2024 to est. 31 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • standard of careDrug

Arms3

  • Placebo comparator

    Type 2 diabetic patients without disordered eating behaviour

    Treated with standard of care.

  • Placebo comparator

    Type 2 diabetic patients with disordered eating behaviour A

    Treated with standard of care.

  • Experimental

    Type 2 diabetic patients with disordered eating behaviour B

    Receiving semaglutide for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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.

    Registry description

    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.

Secondary outcomes(2)

  1. 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.

    Registry description

    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.

  2. Concentration of incretin hormones (GLP-1, GIP)

    Time frame · At the beginning of the trial (before semaglutide administration)

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2023

9 results

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).

Takahashi et al. 2023Diabetes, obesity & metabolismcited by 21

PMID 36722623DOI 10.1111/dom.14998PUB-36722623

Full text at the publisher9 results
Publisher pageSee results (9)

PubMed tag: none · 2021

8 results

An indirect treatment comparison of the efficacy of semaglutide 1.0 mg versus dulaglutide 3.0 and 4.5 mg.

Pratley et al. 2021Diabetes, obesity & metabolismcited by 20

PMID 34286894PMC9291551DOI 10.1111/dom.14497PUB-34286894

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Indexing hint: Clinical trial · 2015

6 results

Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome.

Jensterle et al. 2015Endocrine researchcited by 66

PMID 25330463DOI 10.3109/07435800.2014.966385PUB-25330463

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2015

8 results

Improvement in binge eating in non-diabetic obese individuals after 3 months of treatment with liraglutide - A pilot study.

Robert et al. 2015Obesity research & clinical practicecited by 75

PMID 25870084DOI 10.1016/j.orcp.2015.03.005PUB-25870084

Full text at the publisher8 results
Publisher pageSee results (8)

More studies

3 studies on this page

Indexing hint: Review · 2021

GLP-1 receptor agonists in the treatment of type 2 diabetes - state-of-the-art.

Nauck et al. 2021Molecular metabolismcited by 1,202

PMID 33068776PMC8085572DOI 10.1016/j.molmet.2020.101102PUB-33068776

Free to read · publisher termsCC BY-NC-ND
Read at source

Indexing hint: Review · 2021

Efficacy of Semaglutide in a Subcutaneous and an Oral Formulation.

Meier et al. 2021Frontiers in endocrinologycited by 87

PMID 34248838PMC8269445DOI 10.3389/fendo.2021.645617PUB-34248838

CC BY
Download PDF

Indexing hint: Review · 2018

Recent updates on GLP-1 agonists: Current advancements & challenges.

Sharma et al. 2018Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapiecited by 221

PMID 30372907DOI 10.1016/j.biopha.2018.08.088PUB-30372907

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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