The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Ne… (NCT04263415) | Clinical Trial Compass
CompletedPhase 4
The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity
Slovenia30 participantsStarted 2019-11-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Informed written consent
* Diagnosed with PCOS by Rotterdam criteria
* BMI \> 30 kg/m2
* Age 18 years-menopause
Exclusion Criteria:
* Severe psychiatric disease including schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
* Current history of neurological disease including traumatic brain surgery
* Current history of diagnosis of type I or type II diabetes or plasma haemoglobin A1c 6.5% at inclusion
* Impaired hepatic function (liver transaminases\>3 times upper normal limit)
* Impaired renal function (estimated glomerular filtration rate (eGFR)\< 50 ml/min
* Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase \>2 times upper limit)
* Bleeding disorders
* Women who are pregnant, breast feeding or have intention of becoming pregnant within the next 9 months
* Women who are planning any operation within the next 6 months
* History of medullary thyroid carcinoma (MTC) and/or family history with MTC and/or multiple endocrine neoplasia syndrome type 2
* Cardiac problems defined as decompensated heart failure (New York Herat Association functional class III or IV), unstable angina pectoris, and/or myocardial infarction within the last 12 months
* Uncontrolled hypertension (systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 110 mmHg
* Receiving GLP-1 agonist within the last 12 months
* Use of any weight-lowering pharmacotherapy within the preceding 3 months
* Contraindication for MR s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
to investigate the effect of semaglutide on taste perception as change in taste sensitivity detected by chemical gustometry evaluated with "Taste strips" test
Timeframe: Changes in taste perception from baseline up to the end of 12th week.
2
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
Timeframe: Change in transcriptomic profile from baseline up to the end of 12th week.