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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

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Completed
CT.gov ID
NCT04263415
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
6.9
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a randomized, single-blind, placebo-controlled clinical triala randomized, single-blind, placebo-controlled clinical trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 2, 2019
Actual Primary Completion Date :
May 8, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: group P

once-weekly injection with placebo pen.

Other: Placebo
once-weekly injection with placebo pen for 16 weeks
Experimental: group S

Once-weekly application of semaglutide

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The impact of sema on taste and tongue transcriptome [Changes in taste sensations using Taste-Streeps and tongue transcriptome using RNA-seq from baseline up to the end of 12th week.]

    Secondary Outcome Measures

    1. The impact of sema on gastric emptying. [Change in gastric emptying from baseline up to the end of 12th week.]

    2. The impact of sema on neural response in central reward processing regions [fMRI change in neural response from baseline to the end of 12th week of therapy.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UMC Ljubljana Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • University Medical Centre Ljubljana

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrej Janez, Clinical professor, Head of the Department of Endocrinology, Diabetes and Metabolic Diseases, University Medical Centre Ljubljana
    ClinicalTrials.gov Identifier:
    NCT04263415
    Other Study ID Numbers:
    • sema in PCOS
    First Posted:
    Feb 10, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Dysgeusia

    Study Results

    No Results Posted as of Oct 6, 2021