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

Primary Purpose

PCOS, Semaglutide, Taste, Altered

Status
Completed
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
Semaglutide
Placebo
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UMC Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

group P

group S

Arm Description

once-weekly injection with placebo pen.

Once-weekly application of semaglutide

Outcomes

Primary Outcome Measures

to investigate the effect of semaglutide on taste perception as change in taste sensitivity detected by chemical gustometry evaluated with "Taste strips" test
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

Secondary Outcome Measures

Change in neural response to visual food cues and taste task as assessed by functional MRI
Change in eating behaviour by using a Slovenian translation of Three-Factor Eating Questionnaire TFEQ-R18.
Change in body weight measured with body weight scale to the nearest 1 kg
Change in body fat mass assessed by a Dual Energy X-ray Absorptiometry
The impact of sema on gastric emptying

Full Information

First Posted
February 5, 2020
Last Updated
September 7, 2023
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04263415
Brief Title
The Effects of Semaglutide on Taste, Tongue Tissue Transcriptome, Gastric Emptying and Central Neural Response in Women With PCOS and Obesity
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Semaglutide, Taste, Altered, Tongue Tissue Transcriptome, Gastric Emptying, Central Neural Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
a randomized, single-blind, placebo-controlled clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group P
Arm Type
Placebo Comparator
Arm Description
once-weekly injection with placebo pen.
Arm Title
group S
Arm Type
Experimental
Arm Description
Once-weekly application of semaglutide
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Other Intervention Name(s)
Ozempic
Intervention Description
semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
once-weekly injection with placebo pen for 16 weeks
Primary Outcome Measure Information:
Title
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.
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
The impact of sema on gastric emptying
Time Frame
Change of gastric emptying from baseline to the end of 12th week of therapy.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UMC Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34281590
Citation
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.
Results Reference
derived

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

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