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

NCT04263415 | Completed Phase 4

• 1 other identifier: sema in PCOS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• The impact of sema on gastric emptying

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

Study Arms (2)

group P

PLACEBO COMPARATOR

once-weekly injection with placebo pen.

Other: Placebo

group S

EXPERIMENTAL

Once-weekly application of semaglutide

Drug: Semaglutide

Interventions

Semaglutide DRUG

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

Also known as: Ozempic

group S

Placebo OTHER

once-weekly injection with placebo pen for 16 weeks

group P

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed written consent
• Diagnosed with PCOS by Rotterdam criteria
• BMI \> 30 kg/m2
• Age 18 years-menopause

You may not qualify if:

• Severe psychiatric disease including schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
• Current history of neurological disease including traumatic brain surgery
• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 34281590 DERIVED

MeSH Terms

Conditions

Dysgeusia

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Taste Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor, Head of the Department of Endocrinology, Diabetes and Metabolic Diseases

Model Details: a randomized, single-blind, placebo-controlled clinical trial

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 10, 2020
• Study Start: November 2, 2019
• Primary Completion: May 8, 2020
• Study Completion: October 31, 2021
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)