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Trial · Interventional

TerminatedPhase 4Registry data

Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes

Short name GLP1 et Goût

NCTNCT02674893 (opens ClinicalTrials.gov in a new tab)Other idBRINDISI 2013
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
48 participants (actual)
Sponsor
Centre Hospitalier Universitaire Dijon · Other
Design
Not stated
Countries
1 country

France

Start
4 Feb 2014
Primary completion
31 Aug 2016
Completion
31 Aug 2016
First posted
5 Feb 2016 (estimated)
Last update posted
9 Feb 2026
Conditions
Type 2 Diabetes · Overweight

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 4

    GLP1 et Goût

    NCT02674893

    4 Feb 2014 to 31 Aug 2016

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research. Distribution in groups * 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1) * 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2) * 30 healthy subjects (non-diabetics) (group 3) This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).

Interventions

  • LiraglutideDrug
  • Observation aloneOther

Arms3

  • Experimental

    type 2 diabetics treated with GLP1 analogue

  • Active comparator

    Type 2 diabetics not treated with incretins

  • Other

    Healthy subjects

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Modifications in wanting

    Time frame · Up to 3 months

Secondary outcomes(5)

  1. Modifications in gustatory performance

    Time frame · Until 3 months

  2. Modifications in liking

    Time frame · Until 3 months

  3. Modifications in salivation following the presentation of foods

    Time frame · Until 3 months

  4. Modifications in optimal preferences for sweet and fatty tastes

    Time frame · Until 3 months

  5. Anthropometric modifications

    Time frame · Until 3 months

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2019

Proof of concept: Effect of GLP-1 agonist on food hedonic responses and taste sensitivity in poor controlled type 2 diabetic patients.

Brindisi et al. 2019Diabetes & metabolic syndromecited by 33

PMID 31405666DOI 10.1016/j.dsx.2019.06.021PUB-31405666

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE * persons who have provided written informed consent * aged \> 18 years * type 2 diabetes with HbA1C \> 7% * overweight (BMI \> 27) * normal renal function (creatinine clearance \> 50ml/min) * patients to be treated with Liraglutide (patients with type 2 diabetes with HbA1C \> 7.5% and overweight or obesity, whose current treatment is insufficient to control the diabetes). CONTROL DIABETIC PATIENTS * persons who have provided written informed consent * aged \> 18 years * type 2 diabetes with HbA1C \> 7% * overweight (BMI \> 27) * patients for whom treatment with Liraglutide is not indicated * normal renal function (creatinine clearance \> 50ml/min) HEALTHY SUBJECTS * persons who have provided written informed consent * aged \> 18 years Exclusion Criteria: DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE * type 1 diabetes * decompensated congestive heart failure * acute or chronic infection, progressive cancer, liver cirrhosis * ongoing treatment with antibiotics * smoking * chronic alcohol abuse (\>4 glasses a day) * aversion to the products to be eaten or smelled * poor understanding of the cognitive tasks requested * treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs * persons without national health insurance cover * persons under guardianship * hypersensitivity to Liraglutide * pregnancy, breastfeeding * history of acute or chronic pancreatitis * calcitonin level at selection ≥ 50 ng/L * liver disease, defined by a level of alanine aminotransferase (ALAT) ≥ 2.5 times the upper limit of normal (ULN) for reference values CONTROL DIABETIC PATIENTS * type 1 diabetes, * decompensated congestive heart failure, * acute or chronic infection, progressive cancer, liver cirrhosis, * ongoing treatment with antibiotics, * smoking * chronic alcohol abuse (\> 4 glasses a day), * aversion to the products to be eaten or smelled, * poor understanding of the cognitive tasks requested, * treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs. * persons without national health insurance cover * persons under guardianship HEALTHY SUBJECTS * diabetes (type I and II) * sensory disorders * decompensated congestive heart failure, * acute or chronic infection, progressive cancer, liver cirrhosis, * ongoing treatment with antibiotics, * smoking * chronic alcohol abuse (\> 4 glasses a day), * aversion to the products to be eaten or smelled, * poor understanding of the cognitive tasks requested, * treatment interfering with olfactogustatory performance (psychotropic, anti-emetic, anti-ulcer drugs) * persons without national health insurance cover * persons under guardianship * contra-indications to MRI, notably, but not limited to: pace maker, implantable cardiac defibrillators, neurostimulators, cochlear implants, certain implanted automated injection systems (insulin pumps), vascular intracerebral ferromagnetic clips, certain systems to regulate intravascular temperature, myopia requiring the patients to wear spectacle, history of stroke or transient ischemic attack (TIA), metallic foreign body, in particular intraocular or situated near high-risk zones (nervous system, vascular system), claustrophobia….

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