Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes (GLP1 et Goût)

September 3, 2019 updated by: Centre Hospitalier Universitaire Dijon

Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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….

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: Parallel Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: type 2 diabetics treated with GLP1 analogue
Drug: Liraglutide
Active Comparator: Type 2 diabetics not treated with incretins
Other: Observation alone
Other: Healthy subjects
Other: Observation alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modifications in wanting
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Modifications in gustatory performance
Time Frame: Until 3 months
Until 3 months
Modifications in liking
Time Frame: Until 3 months
Until 3 months
Modifications in salivation following the presentation of foods
Time Frame: Until 3 months
Until 3 months
Modifications in optimal preferences for sweet and fatty tastes
Time Frame: Until 3 months
Until 3 months
Anthropometric modifications
Time Frame: Until 3 months
Until 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2014

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRINDISI 2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Overweight

Clinical Trials on Liraglutide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe