A Phase 4 interventional study of Semaglutide and Placebo in PCOS, Semaglutide and Taste, Altered, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-09-08.
Sponsored by University Medical Centre Ljubljana · Phase 4, Interventional, and Treatment
The purpose of the study is to explore the effects of GLP-1 receptor agonist (GLP-1 RA) semaglutide on modulation of taste sensitivity, tongue tissue transcriptome, modulation of neural response in central reward processing regions and gastric emptying rate. In addition, we aim to investigate the associations between semaglutide induced modulation of taste sensitivity, neural responses and gastric emptying with changes in body mass, eating- behavioural pattern, food perception and food intake.
52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.
This study's enrollment of 30 is below the median of 49 across 28 interventional studies indexed under Dysgeusia.
Browse Dysgeusia studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
once-weekly injection with placebo pen.
Other: Placebo
Once-weekly application of semaglutide
Drug: Semaglutide
semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks
Also known as: Ozempic
once-weekly injection with placebo pen for 16 weeks
to investigate the effect of semaglutide on taste perception as change in taste sensitivity detected by chemical gustometry evaluated with "Taste strips" test
Time frame: Changes in taste perception from baseline up to the end of 12th week.
CO-PRIMARY END-POINT : to investigate alteration of transcriptomic profile of human tongue tissue as changes in expression level from baseline to follow up after 12 weeks of treatment, measured by RNA sequencing
Time frame: Change in transcriptomic profile from baseline up to the end of 12th week.
Change in neural response to visual food cues and taste task as assessed by functional MRI
Time frame: Change in neural response to visual food cues and taste task from baseline up to the end of 12th week.
Change in eating behaviour by using a Slovenian translation of Three-Factor Eating Questionnaire TFEQ-R18.
Time frame: Change in eating behaviour from baseline to the end of 12th week of therapy.
Change in body weight measured with body weight scale to the nearest 1 kg
Time frame: Change in body weight from baseline to the end of 12th week of therapy.
Change in body fat mass assessed by a Dual Energy X-ray Absorptiometry
Time frame: Change in body fat mass from baseline to the end of 12th week of therapy.
The impact of sema on gastric emptying
Time frame: Change of gastric emptying from baseline to the end of 12th week of therapy.
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide
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