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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group P | Placebo Comparator | once-weekly injection with placebo pen. |
|
| group S | Experimental | Once-weekly application of semaglutide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| to investigate the effect of semaglutide on taste perception as change in taste sensitivity detected by chemical gustometry evaluated with "Taste strips" test | 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 | Change in transcriptomic profile from baseline up to the end of 12th week. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in neural response to visual food cues and taste task as assessed by functional MRI | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34281590 | Derived | Jensterle M, Ferjan S, Battelino T, Kovac J, Battelino S, Suput D, Vovk A, Janez A. Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial. Trials. 2021 Jul 19;22(1):464. doi: 10.1186/s13063-021-05442-y. |
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a randomized, single-blind, placebo-controlled clinical trial
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| Placebo | Other | once-weekly injection with placebo pen for 16 weeks |
|
| 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 | 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 | Change in body fat mass from baseline to the end of 12th week of therapy. |
| The impact of sema on gastric emptying | Change of gastric emptying from baseline to the end of 12th week of therapy. |
| ID | Term |
|---|---|
| D004408 | Dysgeusia |
| ID | Term |
|---|---|
| D013651 | Taste Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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