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

September 7, 2023 updated by: Andrej Janez, University Medical Centre Ljubljana

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Changes in taste perception from baseline up to the end of 12th week.
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
Time Frame: Change in transcriptomic profile from baseline up to the end of 12th week.
Change in transcriptomic profile from baseline up to the end of 12th week.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in neural response to visual food cues and taste task as assessed by functional MRI
Time Frame: Change in neural response to visual food cues and taste task from baseline up to the end of 12th week.
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.
Time Frame: Change in eating behaviour from baseline to the end of 12th week of therapy.
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
Time Frame: Change in body weight from baseline to the end of 12th week of therapy.
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
Time Frame: Change in body fat mass from baseline to the end of 12th week of therapy.
Change in body fat mass from baseline to the end of 12th week of therapy.
The impact of sema on gastric emptying
Time Frame: Change of gastric emptying from baseline to the end of 12th week of therapy.
Change of gastric emptying from baseline to the end of 12th week of therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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