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

PCOS Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04263415
• Other study ID #: sema in PCOS
• Status: Completed
• Phase: Phase 4
• Start date: November 2, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: September 2023
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 31, 2021
• Est. primary completion date: May 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Neural Response
• Dysgeusia
• Gastric Emptying
• PCOS
• Semaglutide
• Taste, Altered
• Tongue Tissue Transcriptome

Intervention

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

Other:
• Placebo
once-weekly injection with placebo pen for 16 weeks

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	The impact of sema on gastric emptying		Change of gastric emptying from baseline to the end of 12th week of therapy.