The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity

The Effects of Semaglutide on Modulation of Taste Sensitivity, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Responses in Women With PCOS and Obesity: a Randomized, Single-blind, Placebo-controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: PCOS; Gastric Emptying; Semaglutide; Taste, Altered; Tongue Tissue Transcriptome; Central Neural Response
• Intervention / Treatment: Other: Placebo; Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • UMC Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 scanning (magnetic implants, pacemaker, claustrophobia etc)
• Any condition that the investigator feels would interfere with trial participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group P; once-weekly injection with placebo pen.	Other: Placebo; once-weekly injection with placebo pen for 16 weeks
Experimental: group S; 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; Other Names: Ozempic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2019
• Primary Completion (Actual): May 8, 2020
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Taste Disorders; Dysgeusia
• Other Study ID Numbers: sema in PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No