Clinical trial NCT04263415: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: PCOS
Semaglutide
Taste, Altered
Tongue Tissue Transcriptome
Gastric Emptying
Central Neural Response
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomized, single-blind, placebo-controlled clinical trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: to investigate the effect of semaglutide on taste perception as change in taste sensitivity detected by chemical gustometry evaluated with "Taste strips" test
timeFrame: Changes in taste perception from baseline up to the end of 12th week.
measure: 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
timeFrame: Change in transcriptomic profile from baseline up to the end of 12th week.
Secondary outcomes:
measure: Change in neural response to visual food cues and taste task as assessed by functional MRI
timeFrame: Change in neural response to visual food cues and taste task from baseline up to the end of 12th week.
measure: Change in eating behaviour by using a Slovenian translation of Three-Factor Eating Questionnaire TFEQ-R18.
timeFrame: Change in eating behaviour from baseline to the end of 12th week of therapy.
measure: Change in body weight measured with body weight scale to the nearest 1 kg
timeFrame: Change in body weight from baseline to the end of 12th week of therapy.
measure: Change in body fat mass assessed by a Dual Energy X-ray Absorptiometry
timeFrame: Change in body fat mass from baseline to the end of 12th week of therapy.
measure: The impact of sema on gastric emptying
timeFrame: Change of gastric emptying from baseline to the end of 12th week of therapy.
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
References:
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.