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Completed

NCT Number: NCT04263415

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

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.

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Key information

Conditions

PCOS Central Neural Response Dysgeusia Gastric Emptying Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Semaglutide Sensation Disorders Signs and Symptoms Taste Disorders Taste, Altered Tongue Tissue Transcriptome

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks

Other names: Ozempic

Placebo

Other

once-weekly injection with placebo pen for 16 weeks

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. The impact of sema on gastric emptying

    Time frame: Change of gastric emptying from baseline to the end of 12th week of therapy.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Feb 10, 2020
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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