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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02674893
Date of registration: 02/02/2016
Prospective Registration: No
Primary sponsor: Centre Hospitalier Universitaire Dijon
Public title: Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes GLP1 et Goût
Scientific title: Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes
Date of first enrolment: February 4, 2014
Target sample size: 48
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02674893
Study type:  Interventional
Study design:  Intervention model: Parallel Assignment.  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Key inclusion & exclusion criteria

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….



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Overweight
Type 2 Diabetes
Intervention(s)
Drug: Liraglutide
Other: Observation alone
Primary Outcome(s)
Modifications in wanting [Time Frame: Up to 3 months]
Secondary Outcome(s)
Anthropometric modifications [Time Frame: Until 3 months]
Modifications in salivation following the presentation of foods [Time Frame: Until 3 months]
Modifications in gustatory performance [Time Frame: Until 3 months]
Modifications in optimal preferences for sweet and fatty tastes [Time Frame: Until 3 months]
Modifications in liking [Time Frame: Until 3 months]
Secondary ID(s)
BRINDISI 2013
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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