The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity
- Sponsor
- University Medical Centre Ljubljana
- Study ID
- NCT04263415
- Phase
- PHASE4
- Status
- Completed
Conditions
- Central Neural Response
- Gastric Emptying
- PCOS
- Semaglutide
- Taste, Altered
- Tongue Tissue Transcriptome
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Semaglutide — DRUGsemaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks
- Placebo — OTHERonce-weekly injection with placebo pen for 16 weeks
Study Details
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.
Key Dates
- Start date
- Nov 2, 2019
- Status verified
- Sep 2023
- Primary completion
- May 8, 2020
- Completion
- Oct 31, 2021
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: group Ponce-weekly injection with placebo pen.
- Experimental: group SOnce-weekly application of semaglutide
Primary Outcome Measure
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. ]
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