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 — DRUG
    semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks
  • Placebo — OTHER
    once-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 P
    once-weekly injection with placebo pen.
  • Experimental: group S
    Once-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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